Apparatus and methods of dispensing fluid intravenously and flushing lines of intravenous fluid administration systems

ABSTRACT

Apparatus and methods of dispensing fluid intravenously to a subject, and of flushing a line of an intravenous fluid administration apparatus, are provided. The apparatus may include a reservoir pump configured to operate in fluid communication with an upstream source of a first fluid and a downstream pressure-operated valve. The apparatus may also include a port connector configured to operate in fluid communication with at least the pressure-operated valve. The reservoir pump may also be configured to, during operation, automatically refill itself with the first fluid from the first upstream source. The downstream pressure-operated valve may be configured to operate in fluid communication with the reservoir pump and a second fluid source upstream of the pressure-operated valve, and to, during operation, dispense the first fluid to tubing downstream of the pressure-operated valve based on a pressure condition within the pressure-operated valve exceeding a threshold pressure.

RELATED APPLICATIONS

This application is a continuation-in-part application of and claimspriority to U.S. patent application Ser. No. 14/161,528, filed on Oct.16, 2018, which is a continuation-in-part application of and claimspriority to U.S. patent application Ser. No. 15/880,036, filed on Jan.25, 2018, which is a continuation application of and claims priority toU.S. patent application Ser. No. 15/405,746, filed on Jan. 13, 2017, theentireties of which are herein incorporated by reference.

FIELD

The present disclosure is directed generally to intravenous fluidadministration systems and more particularly to apparatus and methods ofdispensing fluid intravenously to a subject, and of flushing a line ofan intravenous fluid administration system.

DESCRIPTION OF THE RELATED ART

Conventional intravenous (IV) fluid administration systems include astopcock (e.g. 3-way stopcock) which is utilized to control the deliveryof different IV fluids to a subject (e.g. a human patient). For example,FIG. 1 is a perspective view of a conventional IV fluid administrationsystem. As illustrated in FIG. 1, a conventional IV fluid administrationsystem 100 includes an IV fluid bag 110, a drip chamber 120, a thumbwheel regulator (TWR) 130, a stopcock 140, tubing 152 interconnectingthe various components, and a stand 190 which supports and retains theIV bag 110 at an appropriate height above the subject (not shown) toeffect the gravity flow of IV fluids to the subject. Typically, thelower end of tubing 152 (not shown) below stopcock 140 is connected to avascular access device (not shown) (e.g. a needle) that is inserted intoa vein of the subject (not shown) to administer IV fluids.

FIG. 1 illustrates a conventional three-way stopcock 140 including athree-way switch 142 and a port 145. In the illustrated configuration(FIG. 1), switch 142 is positioned in an “on to the subject” positionsuch that IV fluid will drain from IV bag 110, through tubing 152, dripchamber 120, TWR 130, and stopcock 140, and into downstream tubing foradministration to the subject. In many procedures, a pre-determinedamount of a different IV fluid (e.g. drug, antibiotic, anesthetic, etc.)must also be administered to the subject. In such instances, switch 142is manipulated to an “off to the subject” position (not shown), asyringe (not shown), including a pre-determined amount of the differentIV fluid, is inserted into port 145 and is then operated to dispense thedifferent IV fluid into the stopcock 140 and downstream tubing foradministration to the subject.

Typically, the stopcock 140 and downstream tubing must be flushed toensure that all of the predetermined amount of the different IV fluid isadministered to the subject. Conventionally, with switch 142 manipulatedto an “off to the subject” position (not shown), one or more differentsyringes (not shown), either respectively pre-filled with flushing IVfluid or flushing IV fluid is drawn into each respective syringe barrel,is respectively inserted into port 145 and operated to flush thestopcock 140 and downstream tubing. If the same port 145 is used forinjecting both the different IV fluid (e.g. drug, antibiotic,anesthetic, etc.) and the flushing IV fluid, the port 145 must besterilized (e.g. with alcohol) before inserting the flushing IV fluidsyringe. This process may be repeated numerous times to perform theflush for a single different IV fluid (e.g. drug, antibiotic,anesthetic, etc.), and several different IV fluids may need to beinjected, and flushed, while administering IV fluids to a given subject.This process is laborious and time-consuming, and syringes, especiallypre-filled syringes, are expensive. The required amount of syringes inthis conventional process also contributes to a significant amount ofenvironmental waste.

Another conventional technique for flushing IV lines involves squeezingIV bag 110 (with switch 142 positioned in the “on to the subject”position) to force IV fluid through stopcock 140 and tubing downstreamof stopcock 140. However, such a procedure may flood spike and dripchamber 120, rendering it useless, and administers an inaccuratequantity of flushing IV fluid into the subject.

SUMMARY OF THE INVENTION

In some embodiments, an apparatus for dispensing fluid intravenously toa subject is provided that includes a first pressure-operated valveconfigured to operate in fluid communication with an upstream firstsource of a first fluid and an upstream reservoir pump configured toautomatically refill itself with a second fluid from a second upstreamfluid source. The first pressure-operated valve is also configured to,during operation, pass therethrough to tubing downstream of the firstpressure-operated valve, under a first pressure condition, the firstfluid from the upstream first fluid source. The first pressure-operatedvalve is also configured to, during operation, pass therethrough to thetubing downstream of the first pressure-operated valve, under a secondpressure condition, the second fluid from the upstream reservoir pump,wherein the second pressure condition is a condition of higher pressurethan the first pressure condition.

In various embodiments, an apparatus for dispensing fluid intravenouslyto a subject is provided that includes a reservoir pump configured tooperate in fluid communication with an upstream source of a first fluidand a downstream pressure-operated valve. The reservoir pump is alsoconfigured to, during operation, automatically refill itself with thefirst fluid from the first upstream source. The downstreampressure-operated valve is configured to operate in fluid communicationwith the reservoir pump and a second fluid source upstream of thepressure-operated valve. The downstream pressure-operated valve is alsoconfigured to, during operation, dispense the first fluid to tubingdownstream of the pressure-operated valve based on a pressure conditionwithin the pressure-operated valve exceeding a threshold pressure.

In various embodiments, a method of flushing a line of an intravenousfluid administration system is provided including introducing a firstfluid into tubing configured to transport fluid for intravenous infusionto a subject and operating a reservoir pump upstream of the tubing todispense a predetermined amount of a second fluid through apressure-operated valve upstream of the tubing and at a fluid pressureexceeding a threshold pressure of the pressure-operated valve. Themethod also includes releasing the reservoir pump such that thereservoir pump automatically fills itself with the predetermined amountof the second fluid from a source upstream of the reservoir pump andsuch that the pressure-operated valve automatically reconfigures itselfto receive a third fluid from a fluid source upstream of thepressure-operated valve and at a fluid pressure less than the thresholdpressure.

In various embodiments, an apparatus for dispensing fluid intravenouslyto a subject is provided and includes a chamber comprising a pluralityof connector ports. The chamber is configured to operate in fluidcommunication with an upstream first source of a first fluid via a firstone of the plurality of connector ports. The chamber is also configuredto, during operation, pass therethrough to tubing downstream of thechamber, under a first pressure condition, the first fluid from theupstream first fluid source via a second one of the plurality ofconnector ports. A third one of the plurality of connector ports isconfigured to connect to an end of tubing or a valve connector suchthat, during operation, the chamber is configured to, under a secondpressure condition higher than the first pressure condition, passtherethrough to the tubing downstream of the chamber a second fluid froma second fluid source via the third and second connector ports, preventflow of the first fluid into the tubing downstream of the chamber, andprevent flow of the second fluid through the first connector port.

In some embodiments, a method of flushing a line of an intravenous fluidadministration system is provided including introducing a first fluidinto tubing configured to transport fluid for intravenous infusion to asubject via a first connector port and a second connector port of achamber comprising a plurality of connector ports and at a fluidpressure exceeding a threshold pressure of the chamber. The method alsoincludes introducing a second fluid into the tubing via a thirdconnector port and the second connector port of the chamber and at afluid pressure exceeding the threshold pressure of the chamber. In eachof the introducing steps of the method, the flow of the first fluid orthe second fluid through a fourth connector port of the chamber isautomatically prevented.

In various embodiments, a method includes operably coupling a first oneof a plurality of connector ports of a chamber to an upstream firstsource of a first fluid such that the chamber is configured to, duringoperation, pass therethrough to tubing downstream of the chamber, undera first pressure condition, the first fluid via a second one of theplurality of connector ports. The method also includes operably couplingan end of tubing or a valve connector to a third one of the plurality ofconnector ports of the chamber such that, during operation, the chamberis configured to, under a second pressure condition higher than thefirst pressure condition pass therethrough to the tubing downstream ofthe chamber a second fluid from a second fluid source via the third andsecond connector ports, prevent flow of the first fluid into the tubingdownstream of the chamber, and prevent flow of the second fluid throughthe first connector port.

BRIEF DESCRIPTION OF THE DRAWINGS

Various aspects of the present disclosure will be or become apparent toone with skill in the art by reference to the following detaileddescription when considered in connection with the accompanyingexemplary non-limiting embodiments.

FIG. 1 is a perspective view of a conventional intravenous (IV) fluidadministration system.

FIG. 2 is a perspective view of an intravenous (IV) fluid administrationsystem according to some embodiments of the present disclosure.

FIG. 3A is a plan view of an example of a reservoir pump receiving fluidfrom an upstream fluid source according to some embodiments.

FIG. 3B is a plan view of an example of a reservoir pump dispensingfluid to a downstream fluid sink according to some embodiments.

FIG. 3C is a plan view of an example of a reservoir pump including anadjustable filling volume and receiving fluid from an upstream fluidsource according to some embodiments.

FIG. 3D is a plan view of an example of a reservoir pump including anadjustable filling volume and dispensing fluid to a downstream fluidsink according to some embodiments.

FIG. 3E is a plan view of an example of a reservoir pump including anadjustable filling volume and receiving fluid from an upstream fluidsource according to some embodiments.

FIG. 4A is a plan view of an example of a reservoir pump receiving fluidfrom an upstream fluid source according to some embodiments.

FIG. 4B is a plan view of an example of a reservoir pump including anadjustable filling volume and receiving fluid from an upstream fluidsource according to some embodiments.

FIG. 5A is a plan view of an example of a pressure-operated valve undera first pressure condition according to some embodiments of the presentdisclosure.

FIG. 5B is a plan view of an example of a pressure-operated valve undera second pressure condition according to some embodiments of the presentdisclosure.

FIG. 5C is a plan view of an example of a pressure-operated valve undera first pressure condition according to some embodiments of the presentdisclosure.

FIG. 5D is a plan view of an example of a pressure-operated valve undera first pressure condition according to some embodiments of the presentdisclosure.

FIG. 5E is a plan view of an example of a pressure-operated valve undera second pressure condition according to some embodiments of the presentdisclosure.

FIG. 5F is a plan view of an example of a pressure-operated valve undera first pressure condition according to some embodiments of the presentdisclosure.

FIG. 6 is a perspective view of an intravenous (IV) fluid administrationsystem according to some embodiments of the present disclosure.

FIG. 7 is a plan view of an example of a manifold according to someembodiments.

FIG. 8 is a perspective view of an intravenous (IV) fluid administrationsystem according to some embodiments of the present disclosure.

FIG. 9 is a flow chart illustrating a method of flushing a line of anintravenous fluid administration system according to some embodiments.

FIG. 10A is a plan view of an example of a chamber according to someembodiments of the present disclosure.

FIG. 10B is a plan view of an example of a chamber including a pluralityof connector ports according to some embodiments of the presentdisclosure.

FIG. 10C is a plan view of an example of a chamber including a pluralityof connector ports, and examples of valve connectors, according to someembodiments of the present disclosure.

FIG. 10D is a plan view of an example of a chamber including a pluralityof connector ports respectively connected to ends of tubing and anexample of a valve connector according to some embodiments of thepresent disclosure.

FIG. 10E is a plan view of an example of a chamber including a pluralityof connector ports respectively connected to ends of tubing and anexample of a valve connector according to some embodiments of thepresent disclosure.

FIG. 10F is a plan view of an example of a chamber including a pluralityof connector ports respectively connected to ends of tubing and anexample of a valve connector according to some embodiments of thepresent disclosure.

FIG. 10G is a plan view of an example of a chamber including a pluralityof connector ports respectively connected to ends of tubing and anexample of a valve connector according to some embodiments of thepresent disclosure.

FIG. 11 is a perspective view of an intravenous (IV) fluidadministration system according to some embodiments of the presentdisclosure.

FIG. 12 is a flow chart illustrating a method of flushing a line of anintravenous fluid administration system according to some embodiments.

FIG. 13 is a flow chart illustrating a method according to someembodiments of the present disclosure.

FIGS. 14A-14C are perspective views of intravenous (IV) fluidadministration systems according to some embodiments of the presentdisclosure.

FIG. 15 is a plan view of an example of a reservoir pump including aport connector receiving fluid from an upstream fluid source accordingto some embodiments.

FIG. 16 is a plan view of an example of a closed system reservoir pumpreceiving fluid from an upstream fluid source according to someembodiments.

FIG. 17 is a plan view of another example of a closed system reservoirpump receiving fluid from an upstream fluid source according to someembodiments.

FIG. 18 is a plan view of an example of a flow control device under afirst pressure condition according to some embodiments.

FIG. 19 is a plan view of another example of a flow control device undera first pressure condition according to some embodiments.

FIG. 20 is a perspective view of an intravenous (IV) fluidadministration system including a flow control device and a foot switchaccording to some embodiments of the present disclosure.

FIG. 21 is a plan view of an example of a reservoir pump receiving fluidfrom an upstream fluid source according to some embodiments.

DETAILED DESCRIPTION OF THE EXAMPLES

With reference to the Figures, where like elements have been given likenumerical designations to facilitate an understanding of the drawings,the various embodiments of apparatus and methods of dispensing fluidintravenously to a subject, and of flushing a line of an intravenousfluid administration system, are described. The Figures are not drawn toscale.

The following description is provided as an enabling teaching of arepresentative set of examples. Many changes can be made to theembodiments described herein while still obtaining beneficial results.Some of the desired benefits discussed below can be obtained byselecting some of the features or steps discussed herein withoututilizing other features or steps. Accordingly, many modifications andadaptations, as well as subsets of the features and steps describedherein are possible and can even be desirable in certain circumstances.Thus, the following description is provided as illustrative and is notlimiting.

This description of illustrative embodiments is intended to be read inconnection with the accompanying Figures, which are to be consideredpart of the entire written description. In the description ofembodiments disclosed herein, any reference to direction or orientationis merely intended for convenience of description and is not intended inany way to limit the scope of the present disclosure. Relative termssuch as “lower,” “upper,” “horizontal,” “vertical,” “above,” “below,”“up,” “down,” “top” and “bottom” as well as derivative thereof (e.g.,“horizontally,” “downwardly,” “upwardly,” etc.) should be construed torefer to the orientation as then described or as shown in the drawingunder discussion. These relative terms are for convenience ofdescription only and do not require that the apparatus be constructed oroperated in a particular orientation. Terms such as “attached,”“affixed,” “connected” and “interconnected,” refer to a relationshipwherein structures are secured or attached to one another eitherdirectly or indirectly through intervening structures, as well as bothmovable or rigid attachments or relationships, unless expresslydescribed otherwise. The term “adjacent” as used herein to describe therelationship between structures/components includes both direct contactbetween the respective structures/components referenced and the presenceof other intervening structures/components between respectivestructures/components.

As used herein, use of a singular article such as “a,” “an” and “the” isnot intended to exclude pluralities of the article's object unless thecontext clearly and unambiguously dictates otherwise.

Improved intravenous fluid administration systems, methods of dispensingfluid intravenously to a subject using such systems, and methods offlushing a line of such systems are provided. The processes describedherein are not limited to any specific configuration of an intravenousfluid administration system, nor any specific intravenous fluid. Theinventor has developed apparatus and methods of efficiently,cost-effectively, and accurately, dispensing fluid intravenously to asubject, and of efficiently, cost-effectively, and accurately, flushinga line of an intravenous fluid administration system.

The inventor has observed that by utilizing a reservoir pump configuredto automatically refill itself with an IV flushing fluid from anupstream IV fluid source and a downstream pressure-operated valve, thetime, cost, and environmental waste, necessary for using syringes isminimized. The inventor has also observed that by utilizing a reservoirpump configured to automatically refill itself with an IV flushing fluidfrom an upstream IV fluid source and a downstream pressure-operatedvalve, no re-positioning of stopcock switches, and no switching ofsyringes, is required which results in significant time and costsavings, and provides environmental benefits with the reduction ofenvironmental waste. The inventor has further determined that suchsolutions are easily scalable such that numerous different IV fluids canbe injected and flushed efficiently, cost-effectively, and accurately.The inventor has additionally observed that utilizing a chamberincluding a plurality of connector ports, where at least the connectorport configured to receive fluid from a gravity-fed IV fluid source isautomatically operated, the time and cost necessary for using stopcocksis eliminated. These solutions therefore offer significant improvementsin the administration of IV fluids to subjects.

FIG. 2 is a perspective view of an intravenous (IV) fluid administrationsystem 200 according to some embodiments of the present disclosure. Asillustrated in FIG. 2, some embodiments include a first source of afirst IV fluid such as, for example, an IV fluid bag 210, a plastic IVbottle (not shown), a glass IV bottle (not shown), etc. Any suitablefluid for intravenous administration to a subject may be provided as thefirst IV fluid. In various embodiments, the first IV fluid is a solutionincluding saline (e.g. 0.9% sodium chloride (NaCl)). In someembodiments, the first IV fluid is a solution including dextrose (e.g.5% dextrose). In some embodiments, the first IV fluid is a solutionincluding heparin. In some embodiments, the first IV fluid is a solutionincluding one or more additives. For example, a first IV fluid solutionmay include electrolytes such as, for example, lactated Ringer'ssolution, and/or vitamins. In some embodiments, the first IV fluid is asolution including saline and dextrose.

As shown in FIG. 2, IV fluid administration system 200 may include adrip chamber 220, a roller clamp such as, for example, thumb wheelregulator (TWR) 230, tubing 252 upstream of drip chamber 220, betweendrip chamber 220 and TWR 230, and downstream of TWR 230, a stopcock 240,and a stand 290 configured to support and retain the first IV fluidsource 210 at an appropriate height above the subject (not shown) toeffect the gravity flow of the first IV fluid to the subject. Anysuitable tubing may be provided as tubing 252 such as, for example,flexible, plastic tubing. In some embodiments, vented tubing may beutilized. In some embodiments, an air vent (not shown) is included abovedrip chamber 220. In various embodiments, a spike (not shown) isincluded above drip chamber 220, and at an upper or proximal end oftubing 252, to initiate the flow of the first IV fluid from the first IVfluid source (e.g. IV fluid bag 210). In various embodiments, stopcock240 is not included in IV fluid administration system 200.

In various embodiments, a lower or distal end of tubing (not shown)downstream of stopcock 240 is connected to a vascular access device (notshown), such as, for example, a needle (e.g. a butterfly needle), aperipherally inserted central catheter, an over-the-needle catheter, acentral venous catheter, a cannula, etc., that is inserted into a veinof the subject (not shown) to administer IV fluids. In variousembodiments, the vein is a cephalic, basilica, or median cubital vein inthe hand or forearm of a subject. In various embodiments, a male orfemale adapter (not shown) connects the lower or distal end of tubing(not shown) to a female or male hub of a vascular access device (notshown). In some embodiments, a locking collar can be utilized to furthersecure the connection between a lower or distal end of tubing (notshown) and hub of a vascular access device (not shown).

In various embodiments, IV fluid administration system 200 includes apressure-operated valve 270. In various embodiments, pressure-operatedvalve 270 is configured to operate in fluid communication with first IVfluid source 210, illustrated as upstream from pressure-operated valve270 via tubing 252, and a reservoir pump 260, also illustrated asupstream from pressure-operated valve 270 via tubing 256. In variousembodiments, reservoir pump 260 may be operably coupled to, and upstreamfrom, pressure operated valve 270 without intervening tubing 256. Invarious embodiments, pressure-operated valve 270 includes male and/orfemale ends to connect to an end of upstream tubing 252 and an end ofdownstream tubing 252. In some embodiments, a male and/or female adaptermay be utilized to connect pressure-operated valve 270 to an end ofupstream tubing 252 and an end of downstream tubing 252.

In various embodiments, reservoir pump 260 is configured toautomatically refill itself with a second IV fluid from a secondupstream IV fluid source. In various embodiments, reservoir pump 260includes male and/or female ends to connect to an end of upstream tubing254 and an end of downstream tubing 252. In some embodiments, a maleand/or female adapter may be utilized to connect pressure-operated valve270 to an end of upstream tubing 252 and an end of downstream tubing256. As illustrated in FIG. 2, the first and second upstream fluidsources may be the same source (e.g. IV fluid bag 210) and the first andsecond fluids may be the same type of fluid (e.g. a solution includingsaline). In various embodiments, respective upper or proximal ends oftubing 252 (e.g. upstream of pressure-operated valve 270) and tubing 254(e.g. upstream of reservoir 260) are configured to operate in fluidcommunication with the same IV fluid source (e.g. IV fluid bag 210) viaa Y-split of tubing (e.g. Y-split 280 in FIGS. 14A-14C). In variousembodiments, the second upstream fluid source may be a different fluidsource (not shown) than the first upstream fluid source (e.g. IV fluidbag 210). In various embodiments, the second fluid may be a differenttype of fluid than the first fluid. For example, the first fluid may bea solution including saline and dextrose, and the second fluid may be asolution including heparin.

In some embodiments, IV fluid administration system 200 includes anobservation chamber 265 that is configured to operate in fluidcommunication with an upstream IV fluid source (e.g. IV fluid bag 210)and reservoir pump 260, and to provide an indication that, duringoperation, the chamber 265, tubing disposed between the chamber 265 andthe reservoir pump 260 (e.g. tubing 254), and the reservoir pump 260,are filled with IV fluid. In various embodiments, observation chamber265 includes a viewing window or port that permits an operator toobserve the level of second IV fluid in chamber 265 and tubing disposedbetween the chamber 265 and the reservoir pump 260 (e.g. tubing 254). Invarious embodiments, the viewing window or port is graduated to indicatea precise amount of fluid contained in observation chamber 265, indownstream tubing 254, and in reservoir pump 260.

As illustrated in FIG. 2, reservoir pump 260 is configured to operate influid communication with an upstream IV fluid source (e.g. IV fluid bag210) and a downstream pressure-operated valve 270. In variousembodiments, during operation, reservoir pump 260 is configured todispense IV fluid at a fluid pressure into pressure-operated valve 270via tubing 256 and to automatically refill itself with IV fluid from theupstream IV fluid source (e.g. IV fluid bag 210). In variousembodiments, reservoir pump 260 dispenses a predetermined amount of IVfluid into tubing 256 and pressure-operated valve 270 when operated. Anysuitable reservoir pump may be utilized to dispense IV fluid at a fluidpressure into tubing 256 and pressure-operated valve 270. In variousembodiments, IV fluid administration system 200 includes a foot switch(e.g., foot switch 300, shown in FIG. 20 and described in more detailbelow) operably coupled to reservoir pump 260. The foot switch may beconfigured to, in response to a user-applied force on the foot switch,cause reservoir pump 260 to dispense pressurized fluid intopressure-operated valve 270 via tubing 256. In various embodiments, thefoot switch provides for hands-free operation of reservoir pump 260,allowing the user to operate reservoir pump 260 while attending to thepatient.

Referring now to FIG. 3A, a plan view of an example of a reservoir pumpreceiving fluid from an upstream fluid source according to someembodiments is provided. As shown in FIG. 3A, reservoir pump 360 isconnected to tubing 254 and tubing 256. In the illustrated example,reservoir pump 360 includes a plunger assembly including a handle 361and spring 364 operably coupled to a piston 362 positioned withinreservoir pump chamber 363. In various embodiments, reservoir pumpchamber 363 is cylindrically-shaped; however, any suitable shape can beutilized for reservoir pump chamber 363. In various embodiments,reservoir pump chamber 363 is formed from a hard plastic material suchas, for example, polyethylene, polypropylene, polystyrenes, acrylicpolymers, or methacrylic polymers. In some embodiments, reservoir pumpchamber 363 is formed from glass. Reservoir pump 360 may include checkvalves 366 a and 366 b. In the illustrated example, reservoir pump 360includes a normally open swing check valve 366 a and a normally closedswing check valve 366 b. Any suitable check valve may be utilized forcheck valves 366 a and 366 b. For example, a swing check valve, liftcheck valve, wafer check valve, disc check valve, flapper check valve,inline check valve, ball check valve, etc. may be utilized. As shown inFIG. 3A, with piston 362 in its fully retracted position withinreservoir pump chamber 363, check valve 366 a in a normally openedposition, and check valve 366 b in a normally closed position, IV fluidfrom an upstream IV fluid source (e.g. IV fluid bag 210) is receivedinto reservoir pump 360 via tubing 354 until reservoir pump chamber 363is filled.

Referring now to FIG. 3B, a plan view of an example of a reservoir pumpdispensing fluid to a downstream fluid sink according to someembodiments is provided. In the illustrated example, during operation,reservoir pump 360 is configured to dispense IV fluid at a fluidpressure into downstream tubing 356. As shown in FIG. 3B, with handle361 depressed, spring 364 is biased to drive piston 362 into reservoirpump chamber 363 (e.g. laterally) to pressurize the IV fluid inreservoir pump chamber 363. In the illustrated example, the pressurizedIV fluid shuts normally opened check valve 366 a and opens normallyclosed check valve 366 b to dispense pressurized IV fluid into tubing356 via check valve 366 b. For example, an operator (e.g. a clinician)may grasp reservoir pump 360 and depress handle 361 to initiate aflushing operation. In various embodiments, handle 361 is depressed tofully extend piston 362 through the reservoir pump chamber 363 with abiasing force of spring 364 to fully dispense the IV fluid containedtherein into tubing 356 at a fluid pressure. In some embodiments, handle361 may be depressed to only partially extend piston 364 through thereservoir pump chamber 363 such that only a portion of the IV fluidcontained therein is dispensed into tubing 356 at a fluid pressure. Invarious embodiments, reservoir pump chamber 363 is graduated to identifya precise amount of IV fluid contained therein and/or to provide anindication of the precise amount of fluid dispensed during operationthereof. In various embodiments, when the plunger assembly of reservoirpump 360 is released, spring 364 automatically biases the handleoutwardly to carry the piston 362 back through reservoir pump chamber363 to its fully retracted position (e.g. FIG. 3A), check valve 366 are-opens, and check valve 366 b re-shuts. As shown in FIG. 3A, withpiston 362 back in its retracted position within reservoir pump chamber363, check valve 366 a back in its normally opened position, and checkvalve 366 b back in its normally closed position, IV fluid from theupstream IV fluid source (e.g. IV fluid bag 210) is received intoreservoir pump 360 via tubing 354 until reservoir pump chamber 363 isre-filled.

Referring now to FIG. 16, a plan view of an example of a closed systemreservoir pump is provided. In the illustrated example, a collapsiblebellows 377 is coupled at a first end 377 a to the plunger assembly andat a second end 377 b to the housing defining reservoir pump chamber363. In various embodiments, the first end 377 a is coupled to handle361 of the plunger assembly. Alternatively, first end 377 a of thecollapsible bellows may be operably coupled to the shaft connectinghandle 361 and piston 362. In various embodiments, bellows 377 iselastically deformable. In some embodiments, bellows 377 is formed froma compressible, elastomeric material, such as polyisoprene rubber. Insome embodiments, bellows 377 is formed from, for example, low densitypolyethylene, polypropylene, or a thermoplastic elastomer. A closedvolume 378 is defined by bellows 377, the plunger assembly, and thehousing defining reservoir pump chamber 363. Closed volume 378 allowsreservoir pump 360 to be used repeatedly without compromising thesterile and/or aseptic nature of the system. For example, reservoir pump360 may be sterilized (e.g., during manufacturing or prior to use),thereby ensuring that closed volume 378 is in a sterile or asepticcondition. As a result, piston 362, as it is moved inward and outwardwithin chamber 363 during use, contacts only sterile or asepticsurfaces. Hence, contaminants are not introduced into reservoir pumpchamber 363 or dispensed into tubing 356. Reservoir pump 360 may besterilized in any suitable manner, including, for example, in anautoclave, treatment by ethylene oxide or other chemicals (e.g.,hydrogen peroxide, peracetic acid), or through the use of radiation(e.g., non-ionizing or ionizing radiation). In various embodiments,reservoir pump 360 may include a spring (e.g., spring 470, FIG. 20)operably coupled to bellows 377. The spring (e.g., spring 470, FIG. 20)may be configured to provide a restorative force to return bellows 377to its decompressed form. In various embodiments, the spring (e.g.,spring 470, FIG. 20) may be directly coupled to the exterior of bellows377. Alternatively, or additionally, the spring (e.g., spring 470, FIG.20) may contact a plate or other member (not shown) coupled to bellows377 to exert a force thereon. In various embodiments, such a spring(e.g., spring 470, FIG. 20) may be provided in addition to spring 364operably coupled to piston 362 or in lieu of spring 364.

Referring now to FIG. 17, in various embodiments, bellows 377 isoperably coupled nearer the distal end (relative to handle 361) of thehousing defining reservoir pump chamber 363. In such embodiments,bellows 377 may have a longer uncompressed length, thereby allowinggreater travel of piston 362 before fully compressing bellows 377. Asshown in FIG. 17, in various embodiments, reservoir pump 360 includes asleeve 379 at least partially surrounding bellows 377. In variousembodiments, sleeve 379 may be configured to constrain a motion ofbellows 377, thereby preventing buckling, and ensuring substantiallylinear compression, of bellows 377. In various embodiments, sleeve 379may also protect bellows 377 from damage during use, thereby ensuringthat the sterility and/or asepsis of closed volume 378 is maintained.

Referring now to FIGS. 3C and 3E, respective plan views of an example ofa reservoir pump including an adjustable filling volume and receivingfluid from an upstream fluid source according to some embodiments isprovided. In the illustrated example of FIG. 3C, a portion of reservoirpump chamber 363 is externally threaded to engage with an internallythreaded external device 367 (e.g. internally threaded externalcylinder, nut, ring, flange, etc.) such that threading of the externaldevice 367 onto reservoir pump chamber 363 adjusts the retractedposition of piston 362 within reservoir pump chamber 363 to adjust itsfilling volume. With reference now to FIG. 3E, in the illustratedexample, additional threading of external device 367 onto reservoir pumpchamber 363 further adjusts the retracted position of piston 362 withinreservoir pump chamber 363 to adjust its filling volume. As shown in theexamples of FIGS. 3C and 3E, with piston 362 in its respectivelyadjusted retracted position within reservoir pump chamber 363, checkvalve 366 a in a normally opened position, and check valve 366 b in anormally closed position, IV fluid from an upstream IV fluid source(e.g. IV fluid bag 210) is received into reservoir pump 360 via tubing354 until the adjusted volume of reservoir pump chamber 363 is filled.

FIG. 3D provides a plan view of an example of a reservoir pump includingan adjustable filling volume and dispensing fluid to a downstream fluidsink according to some embodiments. In various embodiments, when theplunger assembly of reservoir pump 360 is released, spring 364automatically biases the handle 361 outwardly to carry the piston 362back through reservoir pump chamber 363 to its adjusted retractedposition (e.g. FIG. 3C), check valve 366 a re-opens, and check valve 366b re-shuts. As shown in FIG. 3C, with piston 362 back in its adjustedretracted position within reservoir pump chamber 363, check valve 366 aback in its normally opened position, and check valve 366 b back in itsnormally closed position, IV fluid from the upstream IV fluid source(e.g. IV fluid bag 210) is received into reservoir pump 360 via tubing354 until the adjusted volume of reservoir pump chamber 363 isre-filled. In various embodiments, a reservoir pump (e.g. reservoir pump360) with an adjustable filling volume may include a collapsible bellows(e.g., bellows 377) configured to maintain the sterility and/or asepsisof the reservoir pump during use. In various embodiments, a reservoirpump (e.g. reservoir pump 360) with an adjustable filling volume mayinclude a sleeve (e.g. sleeve 379) at least partially surrounding acollapsible bellows (e.g. bellows 377), that is configured to, forexample, constrain a motion of the collapsible bellows (e.g. bellows377), protect the collapsible bellows (e.g. bellows 377) from damageduring use, etc.

Referring now to FIG. 4A, a plan view of an example of a reservoir pumpreceiving fluid from an upstream fluid source according to someembodiments is provided. In the illustrated example, reservoir pump 460is connected to tubing 454 and tubing 456, and may include check valves466 a and 466 b, as described, for example, in FIGS. 3A-3D. As shown inFIG. 4A, reservoir pump 460 may include a bellows 469. In variousembodiments, bellows 469 is elastically deformable. In some embodiments,bellows 469 is formed from a compressible, elastomeric material, such aspolyisoprene rubber. In some embodiments, bellows 469 is formed from,for example, low density polyethylene, polypropylene, or a thermoplasticelastomer.

As shown in FIG. 4A, with bellows 469 in its fully released position,check valve 466 a in a normally opened position, and check valve 466 bin a normally closed position, IV fluid from an upstream IV fluid source(e.g. IV fluid bag 210) is received into bellows 469 via tubing 454until bellows 469 is filled. During operation, bellows 469 may becompressed to shut normally opened check valve 466 a, open normallyclosed check valve 466 b, and dispense pressurized IV fluid into tubing456 via check valve 466 b. For example, an operator (e.g. a clinician)may grasp and compress bellows 469 to initiate a flushing operation. Invarious embodiments, when bellows 469 is released, it will automaticallyexpand and return to its decompressed form which re-opens check valve466 a, and re-shuts check valve 466 b. In various embodiments, as shownin FIG. 21, reservoir pump 460 may include a spring 470 (e.g., a coilspring) operably coupled to bellows 469. Spring 470 may be configured toprovide additional restorative force to return bellows 469 to itsdecompressed form. In various embodiments, spring 470 may be directlycoupled to the exterior of bellows 469 or, alternatively, spring 470 maycontact a plate or other member (not shown) coupled to bellows 469 tothereby exert a restorative force on bellows 469. As shown in FIG. 4A,with bellows 469 returned to its decompressed form, check valve 466 aback in its normally opened position, and check valve 466 b back in itsnormally closed position, IV fluid from the upstream IV fluid source(e.g. IV fluid bag 210) is received into bellows 469 via tubing 454until bellows 469 is re-filled. As shown in FIG. 4A, reservoir pump 460provides an interior chamber that is closed to the outside environment(e.g., fluid enters only through check valve 466 a via tubing 454 andexits only through check valve 466 b and to tubing 456). In this way,reservoir pump 460 can be used repeatedly without compromising thesterile or aseptic nature of the system. In various embodiments,reservoir pump 460 may include a sleeve (e.g. sleeve 379) at leastpartially surrounding bellows 469, that is configured to, for example,constrain a motion of bellows 469, thereby preventing buckling, andensuring substantially linear compression, of bellows 469. In variousembodiments, a sleeve (e.g. sleeve 379) at least partially surroundingbellows 469 may also protect bellows 469 from damage during use, therebyensuring that the sterility and/or asepsis of the closed interiorchamber of bellows 469 is maintained. In various embodiments, spring 470may be positioned within the sleeve (e.g. sleeve 379) and be configuredto exert a restorative force on bellows 469.

Referring now to FIG. 4B, a plan view of an example of a reservoir pumpincluding an adjustable filling volume and receiving fluid from anupstream fluid source according to some embodiments is provided. In theillustrated example, a compression device 480 (e.g. clamp, ring, flange,locking collar, etc.) restricts the fillable volume of bellows 469 tothe volume forward of the compression device. As shown in FIG. 4B, withcompression device 480 installed surrounding a portion of bellows 469,check valve 466 a in a normally opened position, and check valve 466 bin a normally closed position, IV fluid from an upstream IV fluid source(e.g. IV fluid bag 210) is received into reservoir pump 460 via tubing454 until bellows 469 is filled. In various embodiments, reservoir pump460 with an adjustable filling volume may include a sleeve (e.g. sleeve379) at least partially surrounding bellows 469, that is configured to,for example, constrain a motion of bellows 469, protect bellows 469 fromdamage during use, etc.

As described above for FIG. 4A, during operation, the filled portion ofbellows 469 may be compressed to shut normally opened check valve 466 a,open normally closed check valve 466 b, and dispense pressurized IVfluid from the adjusted filling volume of bellows 469 into tubing 456via check valve 466 b. In various embodiments, when this portion ofbellows 469 is released, it will automatically expand and return to itsdecompressed form which re-opens check valve 466 a, and re-shuts checkvalve 466 b. In various embodiments, reservoir pump 460 may include aspring (e.g., spring 470) operably coupled to bellows 469. The spring(e.g., spring 470) may be configured to provide additional restorativeforce to return bellows 469 to its decompressed form. In variousembodiments, the spring (e.g., spring 470) may be directly coupled tothe exterior of bellows 469 or, alternatively, the spring (e.g., spring470) may contact a plate or other member (not shown) coupled to bellows469 to thereby exert a restorative force on bellows 469. In variousembodiments, during installation or positioning of compression device480, the spring (e.g., spring 470) can be partially or fully compressedto provide access to the exterior of bellows 469. As shown in FIG. 4A,with the filling portion of bellows 469 returned to its decompressedform, check valve 466 a back in its normally opened position, and checkvalve 466 b back in its normally closed position, IV fluid from theupstream IV fluid source (e.g. IV fluid bag 210) is received into thefilling portion of bellows 469 via tubing 454 until this portion ofbellows 469 is re-filled.

Referring again to FIG. 2, in various embodiments, pressure-operatedvalve 270 is configured to, during operation, pass therethrough totubing downstream (e.g. tubing 258) of the pressure-operated valve 270,under a first pressure condition, the first IV fluid from the upstreamfirst fluid source (e.g. IV fluid bag 210), and, during operation, passtherethrough to the tubing downstream (e.g. tubing 258) of thepressure-operated valve 270, under a second pressure condition, thesecond IV fluid from the upstream reservoir pump 260, where the secondpressure condition is a condition of higher pressure than the firstpressure condition. For example, the first pressure may be the fluidpressure of gravity-fed first IV fluid entering pressure-operated valve270 via tubing 252, and the second pressure may be the fluid pressure ofpressurized second IV fluid from reservoir pump 260 enteringpressure-operated valve 270 via tubing 256. Any suitablepressure-operated valve 270 may be utilized to selectively dispenseeither the first IV fluid (e.g. gravity-fed from IV fluid bag 210 viatubing 252) or the second IV fluid (e.g. from reservoir pump 260 viatubing 256) to downstream tubing 258 based on a pressure conditionwithin pressure-operated valve 270. In various embodiments,pressure-operated valve 270 is set at a threshold pressure such that,when such threshold pressure is met and/or exceeded, second IV fluid(e.g. dispensed from reservoir pump 260 via tubing 256), rather thanfirst IV fluid (e.g. gravity-fed from IV fluid bag 210 via tubing 252),is passed therethrough and dispensed to downstream tubing 258.

Referring now to FIG. 5A, a plan view of an example of apressure-operated valve under a first pressure condition according tosome embodiments is provided. As shown in FIG. 5A, pressure-operatedvalve 570 is connected to tubing 252, tubing 258, and tubing 256. In theillustrated example, pressure-operated valve 570 includes a spring 574operably coupled to a piston 572. As shown in FIG. 5A, piston 574 may begenerally “T” shaped in cross section including a longitudinal rodportion that is operably coupled to spring 574 and a transversal rodportion disposed above the same. Any suitable shape may be provided forpiston 572 and spring 574. In various embodiments, spring 574 is biasedat a pre-determined threshold pressure for pressure-operated valve 570.As illustrated in FIG. 5A, during normal operation, second IV fluidpressure from reservoir pump 260 and via tubing 256 is minimal; thus,spring 574 is biased to extend piston 572 toward tubing 256 and first IVfluid gravity-fed from upstream first IV fluid source (e.g. IV fluid bag210) via tubing 252 is passed through pressure-operated valve 570 andinto downstream tubing 258.

Referring now to FIG. 5B, a plan view of an example of apressure-operated valve under a second pressure condition according tosome embodiments is provided. In various embodiments, during a reservoirpump-use operation (e.g. a flushing operation), pressurized second IVfluid is received from reservoir pump 260 and into pressure-operatedvalve 570 via tubing 256. As illustrated in FIG. 5B, the pressurizedsecond IV fluid applies a fluid pressure to piston 572. In theillustrated example, when the fluid pressure received from reservoirpump 260 via tubing 256 is at or exceeds a threshold biasing pressure ofspring 574, piston 572 compresses spring 574 to reposition thetransversal rod portion of piston 572 to block fluid flow from tubing252 and provide fluid communication between the inlet from tubing 256and the outlet to tubing 258. When the fluid pressure received fromreservoir pump 260 via tubing 256 is again less than the thresholdbiasing pressure of spring 574, spring 574 biases piston 572 back towardtubing 256 to re-open the inlet from tubing 252, provide fluidcommunication between the inlet from tubing 252 and the outlet to tubing258, and block fluid flow from tubing 256.

FIG. 5C is a plan view of an example of a pressure-operated valve undera first pressure condition according to some embodiments of the presentdisclosure. In the illustrated example, pressure-operated valve 570 isconnected to tubing 252, tubing 258, and tubing 256, and includes aspring 574 operably coupled to a piston 572 as described above for FIGS.5A-5B. As illustrated in FIG. 5C, pressure-operated valve 570 mayinclude a port connector 575 such as, for example, a luer lockconnector. In various embodiments, pressure-operated valve 570 mayinclude a male or female connector end to connect to an end of a portconnector 575. In various embodiments, port connector 575 may beintegral to pressure-operated valve 570. In various embodiments, afemale end of port connector 575 (e.g. luer lock connector) serves as aconnection point through which a third IV fluid (e.g. drug, antibiotic,anesthetic, etc.) is introduced at a fluid pressure intopressure-operated valve 570 (e.g. via a syringe (not shown)).

The pressurized third IV fluid may apply a fluid pressure to piston 572and, as described above for FIG. 5B and the second IV fluid fromreservoir pump 260 via tubing 256, when the fluid pressure received viaport connector 575 is at or exceeds a threshold biasing pressure ofspring 574, piston 572 compresses spring 574 to reposition thetransversal rod portion of piston 572 to block fluid flow from tubing252 and provide fluid communication between the port connector 575 andthe outlet to tubing 258. When the fluid pressure received via portconnector 575 is again less than the threshold biasing pressure ofspring 574, spring 574 biases piston 572 back toward tubing 256 tore-open the inlet from tubing 252, provide fluid communication betweenthe inlet from tubing 252 and the outlet to tubing 258, and block fluidflow from port connector 575 and tubing 256. In various embodiments,port connector 575 includes a filter (not shown). In some embodimentsport connector 575 includes a normally closed check valve (not shown).In various embodiments, subsequent to injecting a third IV fluid intopressure-operated valve 570 via port connector 575 (e.g. luer lockconnector), a flushing operation using reservoir pump 260 can beinitiated as described above for FIGS. 2, 3A-4B, and 5B. In variousembodiments, port connector 575 may include a valve (not shown). Thevalve may be configured to, during operation of reservoir pump 260,prevent the flow of fluid out through port connector 575. The valve maybe a one-way valve that, for example, allows fluid to flow only from asyringe connected to port connector 575 into the tubingpressure-operated valve 570 and not in the opposite direction. Inaddition, in various embodiments, the valve may prevent pressure withinthe pressure-operated valve 570 from causing a syringe connected to portconnector 575 to be ejected from port connector 575 inadvertently.

FIG. 5D is a plan view of an example of a pressure-operated valve undera first pressure condition according to some embodiments of the presentdisclosure. As shown in FIG. 5D, pressure-operated valve 570 isconnected to tubing 252, tubing 258, and tubing 256. In variousembodiments, pressure-operated valve 570 includes one or more checkvalves. In various embodiments, pressure-operated valve 570 may includea check valve positioned within the valve inlet from tubing 252. Asshown in FIG. 5D, pressure-operated valve 570 may include a check valvepositioned within the valve inlet from tubing 252 and a check valvewithin the valve outlet to tubing 258. In the illustrated example,pressure-operated valve 570 includes a normally open swing check valve576 within the valve inlet from tubing 252 and a normally open disccheck valve 577 within the valve outlet to tubing 258. Any suitablecheck valve may be utilized as check valve 576 and check valve 577. Asillustrated in FIG. 5D, during normal operation, second IV fluidpressure from reservoir pump 260 and via tubing 256 is minimal; thus,first IV fluid gravity-fed from upstream first IV fluid source (e.g. IVfluid bag 210) via tubing 252 is passed through pressure-operated valve570 and into downstream tubing 258. In various embodiments,pressure-operated valve 570 includes a check valve (not shown)positioned within the valve inlet from tubing 256. In variousembodiments, fluid pressure from below check valve 577 (e.g. back flowfrom tubing 258) will operate the disc to shut check valve 577 andprevent any flow of fluid from tubing 258 from enteringpressure-operated valve 570.

Referring now to FIG. 5E, a plan view of an example of apressure-operated valve under a second pressure condition according tosome embodiments is provided. In various embodiments, during a reservoirpump-use operation (e.g. a flushing operation), pressurized second IVfluid is received from reservoir pump 260 and into pressure-operatedvalve 570 via tubing 256. As illustrated in FIG. 5B, the pressurizedsecond IV fluid applies a fluid pressure to shut check valve 576. In theillustrated example, when the fluid pressure received from reservoirpump 260 via tubing 256 is at or exceeds a threshold pressure of checkvalve 576, check valve 576 shuts to block fluid flow from tubing 252 andprovide fluid communication between the inlet from tubing 256 and theoutlet to tubing 258 via check valve 577. When the fluid pressurereceived from reservoir pump 260 via tubing 256 is again less than thethreshold pressure of check valve 576, check valve 576 re-opens tore-open the inlet from tubing 252, and provide fluid communicationbetween the inlet from tubing 252 and the outlet to tubing 258 via checkvalve 577.

FIG. 5F is a plan view of an example of a pressure-operated valve undera first pressure condition according to some embodiments. In theillustrated example, pressure-operated valve 570 is connected to tubing252, tubing 258, and tubing 256, and includes check valves 576 and 577as described above for FIGS. 5E-5F. As illustrated in FIG. 5F,pressure-operated valve 570 may include a port connector 575 (e.g. luerlock connector) as described above for FIG. 5C. In various embodiments,pressurized third IV fluid injected via port connector 575 (e.g. luerlock connector) may apply a fluid pressure to check valve 576 and, asdescribed above for FIG. 5E and the second IV fluid from reservoir pump260 via tubing 256, when the fluid pressure received via port connector575 is at or exceeds a threshold pressure of check valve 576, checkvalve 576 shuts to block fluid flow from tubing 252 and provide fluidcommunication between the inlet from tubing 256 and the outlet to tubing258 via check valve 577. When the fluid pressure received via portconnector 575 is again less than the threshold pressure of check valve576, check valve 576 re-opens to re-open the inlet from tubing 252, andprovide fluid communication between the inlet from tubing 252 and theoutlet to tubing 258 via check valve 577. In various embodiments, portconnector 575 includes a filter (not shown). In some embodiments, portconnector 575 includes a normally closed check valve (not shown). Invarious embodiments, subsequent to injecting a third IV fluid intopressure-operated valve 570 via port connector 575 (e.g. luer lockconnector), a flushing operation using reservoir pump 260 can beinitiated as described above for FIGS. 2, 3A-4B, and 5E.

Turning now to FIGS. 14A-14C, in various embodiments, the IV fluidadministration system 200 can include a port connector 275 at variouspositions within the system. In some embodiments, port connector 275 issubstantially similar to port connector 575, described above. Forexample, port connector 275 may include a luer lock connection. Invarious other embodiments, port connector 275 may be a chamber (e.g.,chamber 1170 shown in 10A-10G) including a plurality of connector ports.In various embodiments, port connector 275 may be used to introduce anIV fluid, such as a medicament, into the IV fluid administration system200 to be delivered to a subject such as, for example, via a female endof port connector 275 (e.g. a luer lock connector). As shown in FIG.14A, port connector 275 may be operably coupled to tubing 252 anddisposed, for example, between drip chamber 220 and pressure operatedvalve 270 (e.g. either upstream or downstream of TWR 230). In variousembodiments, IV fluid injected via port connector 275 (e.g. luer lockconnector) may be injected at a fluid pressure that is at or exceeds athreshold pressure of pressure operated valve 270 and provides fluidcommunication through pressure operated valve 270 between the inlet fromtubing 256 and the outlet to tubing 258.

As shown in FIGS. 14B and 14C, port connector 275 may be disposeddownstream of reservoir pump 260. In various embodiments, subsequent toinjecting an IV fluid into tubing downstream of reservoir pump 260 viaport connector 275, a flushing operation using reservoir pump 260 can beinitiated as described above for FIGS. 2, 3A-4B, and 5E. In variousembodiments, when reservoir pump 260 is operated to flush IV fluid in IVfluid administration system 200, residual IV fluid previously introducedvia port connector 275 may be flushed from tubing downstream of portconnector 275, pressure operated valve 270, downstream tubing 258 andinto a subject. As shown in FIG. 14B, in various embodiments, portconnector 275 is operably coupled to tubing 256 between reservoir pump260 and pressure operated valve 270. In various embodiments, as shown inFIG. 14C, port connector 275 is operably coupled to tubing 258downstream of pressure operated valve 270. With port connector 275 inany of the positions illustrated in FIGS. 14B and 14C, operation ofreservoir pump 260 may flush any residual IV fluids introduced into IVfluid administration system 200 via port connector 275 toward a subject.In one embodiment, IV fluid administration system 200 includes aplurality of port connectors 275 disposed at one or more positionsdescribed herein.

Alternatively, or additionally, as shown in FIG. 15, a port connector375 may be coupled to reservoir pump 360. In various embodiments, portconnector 375 may be integrally formed with a portion of reservoir pump360. In various embodiments, port connector 375 is operably coupled toreservoir pump 360 by any appropriate means (e.g., threaded connection,bonding, press-fit, via a valve connector, etc.). In variousembodiments, port connector 375 may be disposed downstream of checkvalve 366 b (i.e., between check valve 366 b and tubing 356). Hence, asdescribed above, in various embodiments, IV fluids previously introducedthrough port connector 375 may be flushed toward a subject by operationof reservoir pump 360. In various embodiments, a port connector (notshown) may be coupled to reservoir pump 460 (FIGS. 4A-4B) such as, forexample, disposed downstream of check valve 466 b (i.e., between checkvalve 466 b and tubing 456). In various embodiments, a port connector(not shown) may be integrally formed with a portion of reservoir pump460 (e.g. a portion downstream of check valve 466 b), or operablycoupled to reservoir pump 460 by any appropriate means.

In various embodiments, port connector 275 (375) may be disposed betweenreservoir pump 260 (360) and pressure operated valve 270 as illustratedin FIGS. 14B and 15. In various embodiments, IV fluid injected via portconnector 275 (375) may be injected at a fluid pressure that is lessthan a threshold pressure of pressure operated valve 270. In variousembodiments, IV fluids previously introduced through port connector 275(375), and at a fluid pressure less than a threshold pressure ofpressure operated valve 270, are introduced through pressure-operatedvalve 270 and downstream tubing 258 when reservoir pump 260 (360) isoperated as described above. Hence, in various embodiments, the timingof the fluid communication of various IV fluids toward a subject may becontrolled. In various embodiments, operation of IV fluid administrationsystem 200 in a manner in which an IV fluid (e.g. a medicament) isintroduced through port connector 275 (375) at a fluid pressure lessthan a threshold pressure of pressure operated valve 270, and in whichreservoir pump 260 (360) is subsequently operated as described above,may ensure that substantially all of the IV fluid, or IV fluids,introduced through port connector 275 (375) are delivered to a subjectat or about the same time. In various embodiments, port connector 275(375) may include a valve (not shown). The valve may be configured to,during operation of reservoir pump 260 (360), prevent the flow of fluidout through port connector 275 (375). The valve may be a one-way valvethat allows fluid to flow only from a syringe connected to portconnector 275 (375) into the tubing (e.g., 256, 258, 356) and not in theopposite direction. In addition, in various embodiments, the valve mayprevent pressure within the tubing (e.g., 256, 258, 356) from causing asyringe connected to port connector 275 (375) to be ejected from portconnector 275 (375) inadvertently.

As shown in FIG. 18, in various embodiments, an example of a unitaryreservoir pump and a pressure-operated valve is provided and illustratedas an example of a flow control device 1570 under a first pressurecondition. In various embodiments, in a pressure-operated valve portion,flow control device 1570 includes a first inlet port configured to beoperably coupled to first upstream tubing 252 and to operate in fluidcommunication with a source of a first intravenous fluid via firstupstream tubing 252. In various embodiments, flow control device 1570also includes a second inlet port configured to be operably coupled tosecond upstream tubing 254 and to operate in fluid communication with asource of a second intravenous fluid via second upstream tubing 254. Invarious embodiments, the first intravenous fluid and the secondintravenous fluid are the same type of fluid and may be supplied by asingle source. In various embodiments, flow control device 1570 alsoincludes a chamber 1363 defined by a housing. In various embodiments,chamber 1363 is in fluid communication with second upstream tubing 254via the second inlet port of flow control device 1570. In variousembodiments, chamber 1363 has a filling volume and, during operation, areservoir pump portion of flow control device 1570 is configured todispense second intravenous fluid at a fluid pressure through chamber1363 and toward a pressure-operated valve portion of flow control device1570 and to automatically refill chamber 1363 with the secondintravenous fluid via the second inlet port, as described above forreservoir pump 260 (360, 460) for FIGS. 2, 3A-4B. In variousembodiments, in a pressure-operated valve portion, flow control device1570 also includes an outlet port configured to be operably coupled todownstream tubing 258. In the illustrated example, a pressure-operatedvalve portion of flow control device 1570 includes a spring 1574operably coupled to a piston 1572. As described above with reference toFIG. 5A, piston 1572 may be generally “T” shaped in cross sectionincluding a longitudinal rod portion that is operably coupled to aspring 1574 and a transversal rod portion disposed above the same. Anysuitable shape may be provided for piston 1572 and spring 1574. Invarious embodiments, spring 1574 is biased at a pre-determined thresholdpressure for flow control device 1570. As illustrated in FIG. 18, duringnormal operation, second IV fluid pressure in chamber 1363 (from thereservoir pump portion of flow control device 1570) is minimal; thus,spring 1574 is biased to extend piston 1572 toward chamber 1363 andfirst IV fluid gravity-fed from upstream first IV fluid source (e.g. IVfluid bag 210) via first upstream tubing 252 is passed through thepressure-operated valve portion of flow control device 1570 and intodownstream tubing 258.

Upon translation of piston 1362 within chamber 1363 toward piston 1572,the second IV fluid pressure in chamber 1363 of flow control device 1570is increased. As described above with reference to FIG. 5B, thepressurized second IV fluid applies a fluid pressure to piston 1572.When the fluid pressure within chamber 1363 of flow control device 1570is at or exceeds a threshold biasing pressure of spring 1574, piston1572 compresses spring 1574 to reposition the transversal rod portion ofpiston 1572 to block fluid flow from first upstream tubing 252 andprovide fluid communication between the chamber 1363 and the outlet todownstream tubing 258. In addition, with the pressure in chamber 1363 offlow control device 1570 above the threshold pressure, check valve 1366of the second inlet port closes to prevent intravenous fluid fromflowing back from chamber 1363 into second upstream tubing 254. When thefluid pressure in chamber 1363 of flow control device 1570 is again lessthan the threshold biasing pressure of spring 1574, spring 1574 biasespiston 1572 back toward the chamber 1363 (of the reservoir pump portionof flow control device 1570) to re-open the inlet (of thepressure-operated valve portion of flow control device 1570) from firstupstream tubing 252, provide fluid communication between the inlet fromfirst upstream tubing 252 and the outlet to downstream tubing 258, andblock fluid flow from chamber 1363 (of the reservoir pump portion offlow control device 1570).

In a manner similar to that described above with reference to theexample pressure-operated valve of FIGS. 5D-5F, in various embodiments,a pressure-operated valve portion of a flow control device 1570, shownin FIG. 19, may include one or more check valves, for example, in lieuof piston 1572 and spring 1574. In various embodiments, apressure-operated valve portion of flow control device 1570 may includea check valve 1576 positioned within a first inlet port controlling flowfrom first upstream tubing 252 and a check valve 1577 within an outletport controlling flow to downstream tubing 258. As described above forFIGS. 5D-5F, a normally open swing check valve 1576 can be providedwithin the first inlet port of a pressure-operated valve portion of flowcontrol device 1570 from first upstream tubing 252 and a normally opendisc check valve 1577 can be provided within an outlet port todownstream tubing 258. In addition, in various embodiments, flow controldevice 1570 may include a normally closed check valve 1578 betweenchamber 1363 and the pressure-operated valve portion of flow controldevice 1570. Any suitable check valves may be utilized. During normaloperation, second IV fluid pressure from chamber 1363 (of a reservoirpump portion of flow control device 1570) is minimal; thus, first IVfluid gravity-fed from upstream first IV fluid source (e.g. IV fluid bag210) via first upstream tubing 252 is passed through a pressure-operatedvalve portion of flow control device 1570 and into downstream tubing258. In various embodiments, fluid pressure downstream of check valve1577 in the outlet port (e.g. back flow from downstream tubing 258) thatexceeds a threshold pressure of check valve 1577 will operate to shutcheck valve 1577 and prevent any flow of fluid from downstream tubing258 from entering flow control device 1570.

During operation, in various embodiments, pressurized second IV fluidfrom chamber 1363 of a reservoir pump portion of flow control device1570 may apply a fluid pressure to open check valve 1578 between chamber1363 and the pressure-operated valve portion of the flow control device1570. During operation, the pressurized fluid flowing through checkvalve 1578 and into the pressure-operated valve portion of flow controldevice 1570 applies a fluid pressure to shut check valve 1576 in thefirst inlet port (configured to be operably coupled to first upstreamtubing 252) of a pressure-operated valve portion of flow control device1570. In various embodiments, during operation, when the second IV fluidpressure in chamber 1363 of flow control device 1570 is at or exceeds athreshold pressure of first inlet port check valve 1576, check valve1576 shuts to block fluid flow from first upstream tubing 252 andprovide fluid communication between chamber 1363 of a reservoir pumpportion of flow control device 2576 and the outlet of flow controldevice 1576 to downstream tubing 258 via check valve 1577 in the outlet.During operation, when the fluid pressure in chamber 1363 of flowcontrol device 1570 is again less than the threshold pressure of checkvalve 1576 in the first inlet port, check valve 1576 re-opens tore-establish fluid communication of first IV fluid into thepressure-operated valve portion of flow control device 1570 fromupstream tubing 252 via the inlet and toward the outlet to downstreamtubing 258. In various embodiments, when the fluid pressure in chamber1363 of flow control device 1570 is again less than the thresholdpressure of check valve 1578 between chamber 1363 and thepressure-operated valve portion of the flow control device 1570, checkvalve 1578 re-shuts to prevent fluid communication between the reservoirpump portion and the pressure-operated valve portion of flow controldevice 1570.

As shown in FIG. 20, in various embodiments, an example IV fluidadministration system 200 may include a flow control device 1570, asdescribed above, and a port connector 275 disposed downstream of theflow control device 1570. In various embodiments, port connector 275 maybe integrated into flow control device 1570, as described above withreference to FIGS. 5C and 5F. In various embodiments, port connector 275may be operably coupled to flow control device 1570 without interveningtubing. In various embodiments, as shown in FIG. 20, first upstreamtubing 252 and second upstream tubing 254 may be coupled to a spike 212comprising multiple IV fluid distribution chambers (e.g. a dual lumenspike). The inventor has determined that a multi-chamber IV spike 212provides a single spike inserted into IV bag 210 to dispense IV fluidinto first upstream tubing 252 (e.g. toward a first inlet port of adownstream pressure-operated valve portion of a flow control device1570) and into second upstream tubing 254 (e.g. toward a second inletport of a downstream reservoir pump portion of a flow control device1570). In various embodiments, second upstream tubing 254 may bedisposed and held in a close spatial relationship to first upstreamtubing 252 using a sleeve or other external restraint (not shown). Theinventor has determined that maintaining this tubing in a close spatialrelationship may reduce the risk that either the first or secondupstream tubing is inadvertently pulled or caught as IV fluidadministration system 200 is repositioned or as operators, bystanders,subjects, or equipment move around IV fluid administration system 200.In various embodiments (not shown), both the first and second upstreamtubing may pass through a portion of TWR 230, while only the flow of IVfluid through first upstream tubing 252 is regulated by operation of thethumb wheel of TWR 230.

As shown in FIG. 20, in various embodiments, IV fluid administrationsystem 200 may include a foot switch 300. Foot switch 300 may beoperably coupled to flow control device 1570 and may be configured to,in response to a user-applied force on the foot switch 300, cause areservoir pump portion of flow control device 1570 to dispensepressurized fluid into a pressure-operated valve portion of flow controldevice 1570 and into downstream tubing 258. In various embodiments, footswitch 300 may be a foot operated air pump and depression of foot switch300 by a user causes pressurized air to be applied to piston 1362 todrive piston 1362 into chamber 1363. Alternatively, in variousembodiments, foot switch 300 is an electrical foot switch electricallycoupled to flow control device 1570 and depression of foot switch 300causes an electrical signal to be provided to an electromechanical drivemechanism (e.g., a lead screw coupled to an electrical motor) to drivepiston 1362 into chamber 1363. In various embodiments, foot switch 300provides for hands-free operation of flow control device 1570, allowingthe user to operate the reservoir pump portion of flow control device1570 while performing other tasks such as, for example, attending to thesubject.

With reference to FIG. 6, a perspective view of an intravenous (IV)fluid administration system according to some embodiments is provided.As illustrated in FIG. 6, some embodiments include a first source of afirst IV fluid 610 a, a drip chamber 620, a roller clamp 630, tubing 652upstream of drip chamber 620, between drip chamber 620 and roller clamp630, and downstream of roller clamp 630, a stopcock 640, and a stand 690as described above for FIG. 2. In various embodiments, stopcock 640 isnot included in IV fluid administration system 600. In variousembodiments, IV fluid administration system 600 includes a firstpressure operated valve 670 a as described above for pressure operatedvalve 270 (570) for FIGS. 2, 5A-5F. In various embodiments, IV fluidadministration system 600 includes a first reservoir pump 660 a, andtubing 656 a between first reservoir pump 660 a and first pressureoperated valve 670 a, as described above for reservoir pump 260 (360,360) for FIGS. 2, 3A-4B and pressure operated valve 270 (570) for FIGS.2, 5A-5F. In various embodiments, a first reservoir pump 660 a may beoperably coupled to, and upstream from, a first pressure operated valve670 a without intervening tubing 656 a. In various embodiments, IV fluidadministration system 600 includes a first observation chamber 665 a,and tubing 654 a between first reservoir pump 660 a and firstobservation chamber 665 a, as described above for observation chamber265 and reservoir pump 260 (360, 360) for FIGS. 2, 3A-4B. In variousembodiments, first IV fluid source 610 a and the IV fluid source offirst reservoir pump 660 a (not shown) are different IV fluid sources asdescribed above for FIG. 2. In the illustrated embodiments, first IVfluid source 610 a and the IV fluid source of first reservoir pump 660 aare the same IV fluid source (610 a).

The inventor has determined that his solutions described herein areeasily scalable such that numerous different IV fluids can be injectedand flushed efficiently, cost-effectively, and accurately. For example,as shown in FIG. 6, IV fluid administration system 600 may include ananother upstream IV fluid source 610 b and another upstream reservoirpump 660 b configured to automatically refill itself with a third IVfluid from the another upstream IV fluid source 610 b as described abovefor reservoir pump 260 (360, 460) for FIGS. 2, 3A-4B. In the illustratedembodiments, first IV fluid source 610 a and the IV fluid source 610 bof second reservoir pump 660 b are different IV fluid sources. Invarious embodiments, first IV fluid source 610 a and the IV fluid source610 b of second reservoir pump 660 b are the same IV fluid source (notshown). In some embodiments, IV fluid administration system 600 includesa second observation chamber 665 b that is configured to operate influid communication with the another upstream IV fluid source 610 b andthe another upstream reservoir pump 660 b, and to provide an indicationthat, during operation, the second chamber 665 b, tubing disposedbetween the chamber 665 b and the another upstream reservoir pump 660 b(e.g. tubing 654 b), and the another upstream reservoir pump 660 b, arefilled with IV fluid, as described above for observation chamber 265 andreservoir pump 260 (360, 360) for FIGS. 2, 3A-4B.

As illustrated in FIG. 6, the another upstream reservoir pump 660 b isconfigured to operate in fluid communication with the another upstreamIV fluid source 610 b and a downstream second pressure-operated valve670 b as described above for reservoir pump 260 (360, 360) for FIGS. 2,3A-4B and pressure operated valve 270 (570) for FIGS. 2, 5A-5F. Invarious embodiments, during operation, the another upstream reservoirpump 660 b is configured to dispense IV fluid at a fluid pressure intosecond pressure-operated valve 670 b via tubing 656 b and toautomatically refill itself with IV fluid from the another upstream IVfluid source 610 b as described above for reservoir pump 260 (360, 360)for FIGS. 2, 3A-4B and pressure operated valve 270 (570) for FIGS. 2,5A-5F. In various embodiments, the another upstream reservoir pump 660 bdispenses a predetermined amount of IV fluid into tubing 656 b andsecond pressure-operated valve 670 b when operated. Any suitablereservoir pump may be utilized to dispense IV fluid at a fluid pressureinto 656 b and second pressure-operated valve 670 b. In variousembodiments, the another reservoir pump 660 b may be operably coupledto, and upstream from, second pressure operated valve 670 b withoutintervening tubing 656 b.

In the illustrated embodiments, IV fluid administration system 600 mayinclude a second pressure-operated valve 670 b that is configured tooperate in fluid communication with the upstream first IV fluid source610 a (as described above for pressure-operated valve 270 (570) forFIGS. 2, 5A-5F) or the upstream reservoir pump 660 a depending on whichfluid is passing through upstream tubing 658 a. In various embodiments,second pressure-operated valve 670 b is also configured to operate influid communication with another upstream reservoir pump 660 b (asdescribed above for reservoir pump 260 (360, 360) for FIGS. 2, 3A-4B andpressure operated valve 270 (570) for FIGS. 2, 5A-5F) that is configuredto automatically refill itself with a third IV fluid from the anotherupstream IV fluid source 610 b. In various embodiments, neither the IVfluid source of first reservoir pump 660 a (not shown) nor the IV fluidsource of second reservoir pump 660 b (610 b) are the same IV fluidsource as first IV fluid source 610 a. In various embodiments, first IVfluid source 610 a and the IV fluid source of first reservoir pump 660 aare the same IV fluid source (610 a) and the IV fluid source of secondreservoir pump 660 b (610 b) is a different IV fluid source.

In various embodiments, during operation, second pressure-operated valve670 b is configured to pass therethrough to tubing 658 b downstream ofthe second pressure-operated valve 670 b, under a third pressurecondition, the first fluid from the upstream first IV fluid source 610 a(as described above for pressure-operated valve 270 (570) for FIGS. 2,5A-5F) or the second fluid from the first upstream reservoir pump 660 a,and also to, during operation, pass therethrough to the tubing 658 bdownstream of the second pressure-operated valve 670 b, under a fourthpressure condition, the third IV fluid from the another upstreamreservoir pump 660 b (as described above for reservoir pump 260 (360,360) for FIGS. 2, 3A-4B and pressure operated valve 270 (570) for FIGS.2, 5A-5F), where the fourth pressure condition is a condition of higherpressure than the third pressure condition. For example, the thirdpressure may be the fluid pressure of gravity-fed first IV fluidentering second pressure-operated valve 670 b via tubing 658 a, and thefourth pressure may be the fluid pressure of pressurized third IV fluidfrom another reservoir pump 660 b entering second pressure-operatedvalve 670 b via tubing 656 b. The third pressure may be the fluidpressure of pressurized second IV fluid from reservoir pump 660 aentering second pressure-operated valve 670 b via tubing 658 a, and thefourth pressure may be the fluid pressure of pressurized third IV fluidfrom another reservoir pump 660 b entering second pressure-operatedvalve 670 b via tubing 656 b.

Any suitable pressure-operated valve 670 b may be utilized toselectively dispense the first IV fluid (e.g. gravity-fed from IV fluidbag 610 a via tubing 658 a), the second IV fluid (e.g. from reservoirpump 660 a via first pressure-operated valve 670 a and tubing 658 a), orthe third IV fluid (e.g. from another reservoir pump 660 b via tubing656 b) to downstream tubing 658 b based on a pressure condition withinsecond pressure-operated valve 670 b. In various embodiments, secondpressure-operated valve 670 b is set at a threshold pressure such that,when such threshold pressure is met and/or exceeded, third IV fluid(e.g. dispensed from another reservoir pump 660 b via tubing 656 b),rather than first IV fluid (e.g. gravity-fed from IV fluid bag 610 a viatubing 658 b), is passed therethrough and dispensed to downstream tubing658 b. In various embodiments, second pressure-operated valve 670 b isset at a threshold pressure such that, when such threshold pressure ismet and/or exceeded, third IV fluid (e.g. dispensed from anotherreservoir pump 660 b via tubing 656 b), rather than first IV fluid (e.g.gravity-fed from IV fluid bag 610 a via tubing 658 b) or second IV fluid(e.g. from reservoir pump 660 a via first pressure-operated valve 670 aand tubing 658 a), is passed therethrough and dispensed to downstreamtubing 658 b. In various embodiments, the third pressure condition ofsecond pressure-operated valve 670 b is the same as the first pressurecondition of first pressure-operated valve 670 a.

In various embodiments, IV fluid administration system 600 includes oneor more foot switches (e.g., foot switch 300, FIG. 20) operably coupledto reservoir pump 660 a and/or reservoir pump 660 b. The one or morefoot switches may be configured to, in response to a user-applied forceon the foot switch, cause reservoir pump 660 a and/or reservoir pump 660b to dispense pressurized fluid into pressure-operated valve 670 a viatubing 656 a or pressure-operated valve 670 b via tubing 656 b,respectively. In various embodiments, the one or more foot switchesprovide for hands-free operation of reservoir pump 660 and/or reservoirpump 660 b, allowing the user to operate the respective reservoir pumpwhile attending to the subject.

Referring now to FIG. 7, a plan view of an example of a manifoldaccording to some embodiments is provided. In various embodiments,manifold 790 includes a plurality of inter-connected pressure-operatedvalves (770 a, 770 b, 770 c) that operate as described above forpressure-operated valve 270, first pressure-operated valve 670 a, and/orsecond pressure-operated valve 670 b for FIGS. 2, 5A-5F, and/or 6. Invarious embodiments, manifold 790 is connected to tubing 752 and tubing756 a via first pressure operated valve 770 a, to tubing 756 b viasecond pressure operated valve 770 b, and to tubing 756 c, tubing 758,and port (e.g. luer lock connector) 775, via third pressure operatedvalve 770 c. In various embodiments, port 775 is configured to receive aneedle of a syringe (not shown) as described above for port 575. Invarious embodiments, each of the plurality of inter-connectedpressure-operated valves (770 a, 770 b, 770 c) includes one or morerespective check valves (not shown) such as, for example, as describedabove for pressure-operated valve 270 for FIGS. 5D-5F.

As shown in FIG. 7, third pressure operated valve 770 c may beconfigured to operate in fluid communication with an upstream firstsource of first IV fluid (e.g. 610 a) via tubing 752, first pressureoperated valve 770 a, and second pressure operated valve 770 b, with afirst upstream reservoir pump (e.g. reservoir pump 260 or 660 a) viatubing 756 a, first pressure operated valve 770 a, and second pressureoperated valve 770 b, with a second upstream reservoir pump (e.g.reservoir pump 660 b) via tubing 756 b and second pressure operatedvalve 770 b, with a syringe via port 775 (e.g. luer lock connector), andwith a third upstream reservoir pump via tubing 756 c. In variousembodiments, third pressure operated valve 770 c may be configured to,during operation, pass therethrough to tubing 758 downstream of thethird pressure operated valve 770 c, under a fifth pressure condition,the first IV fluid from the upstream first fluid source 610 a (asdescribed above for pressure-operated valve 270 (570) for FIGS. 2,5A-5F) and also to, during operation, pass therethrough to the tubing758 downstream of the third pressure operated valve 770 c, under a sixthpressure condition, a fourth IV fluid from the syringe (as describedabove for reservoir pump 260 (360, 460) for FIGS. 2, 3A-4B and portconnector 575 for FIGS. 5C, 5F), where the sixth pressure condition is acondition of higher pressure than the fifth pressure condition.

In various embodiments, third pressure operated valve 770 c may beconfigured to, during operation, pass therethrough to tubing 758downstream of the third pressure operated valve 770 c, under a fifthpressure condition, the first IV fluid from the upstream first fluidsource 610 a (as described above for pressure-operated valve 270 (570)for FIGS. 2, 5A-5F), the second IV fluid from the first upstreamreservoir pump (e.g. 260 or 660 a), or the third IV fluid from thesecond upstream reservoir pump (e.g. 260 or 660 b), and also to, duringoperation, pass therethrough to the tubing 758 downstream of the thirdpressure operated valve 770 c, under a sixth pressure condition, afourth IV fluid from the third upstream reservoir pump (e.g. 260) (asdescribed above for reservoir pump 260 (360, 460) for FIGS. 2, 3A-4B andpressure-operated valve 270 (570) for FIGS. 2, 5A-5F), where the sixthpressure condition is a condition of higher pressure than the fifthpressure condition.

For example, the fifth pressure may be the fluid pressure of gravity-fedfirst IV fluid entering second pressure-operated valve 670 b via tubing658 a, and the sixth pressure may be the fluid pressure of pressurizedfourth IV fluid from the third upstream reservoir pump (not shown)entering third pressure-operated valve 770 c via tubing 756 c or ofpressurized fourth IV fluid from a syringe (not shown) entering thirdpressure-operated valve 770 c via port 775. The fifth pressure may bethe fluid pressure of pressurized second IV fluid from the firstupstream reservoir pump (e.g. 260 or 660 a) entering manifold 700 viatubing 756 a or pressurized third IV fluid from the second upstreamreservoir pump (e.g. 260 or 660 b) entering manifold 700 via tubing 756b, and the sixth pressure may be the fluid pressure of pressurizedfourth IV fluid from the third upstream reservoir pump (not shown)entering third pressure-operated valve 770 c via tubing 756 c.

With reference to FIG. 8, a perspective view of an intravenous (IV)fluid administration system according to some embodiments is provided.As illustrated in FIG. 8, some embodiments include a source of a firstIV fluid 810, a drip chamber 820, a roller clamp 830, and tubing 852downstream of roller clamp 830 as described above for FIG. 2. In variousembodiments, IV fluid administration system 800 includes a pressureoperated valve 870 as described above for pressure operated valve 270(570) for FIGS. 2, 5A-5F. In various embodiments, IV fluidadministration system 800 includes a reservoir pump 860, and tubing 856between reservoir pump 860 and pressure operated valve 870, as describedabove for reservoir pump 260 (360, 360) for FIGS. 2, 3A-4B and pressureoperated valve 270 (570) for FIGS. 2, 5A-5F. In various embodiments, areservoir pump 860 may be operably coupled to, and upstream from, apressure operated valve 870 a without intervening tubing 856. In variousembodiments, IV fluid administration system 800 includes tubing 854between reservoir pump 860 and a source of a IV fluid 810 for reservoirpump 860, as described above for reservoir pump 260 (360, 360) for FIGS.2, 3A-4B. In various embodiments, first IV fluid source 810 and the IVfluid source of reservoir pump 860 (not shown) are different IV fluidsources as described above for FIG. 2. In the illustrated embodiments,first IV fluid source 810 and the IV fluid source of reservoir pump 860are the same IV fluid source 810 a. As shown in FIG. 8, IV fluidadministration system 800 does not include a stopcock or an observationchamber between reservoir pump 860 and source of IV fluid 810 forreservoir pump 860. In various embodiments, IV fluid administrationsystem 800 includes a foot switch (e.g., foot switch 300, FIG. 20)operably coupled to reservoir pump 860. The foot switch may beconfigured to, in response to a user-applied force on the foot switch,cause reservoir pump 860 to dispense pressurized fluid intopressure-operated valve 870 via tubing 856. In various embodiments, thefoot switch provides for hands-free operation of reservoir pump 860,allowing the user to operate reservoir pump 860 while attending to thesubject.

Referring now to FIG. 9, a flow chart illustrating a method 900 offlushing a line of an intravenous fluid administration system (e.g. IVfluid administration system 200, 600, 800) according to some embodimentsis provided. At block 910, a first IV fluid is introduced into tubing(e.g. tubing 258, tubing 858) configured to transport fluid forintravenous infusion to a subject. At block 920, a reservoir pump (e.g.reservoir pump 260, reservoir pump 860), that is positioned upstream ofthe tubing (e.g. tubing 258, tubing 858), is operated to dispense apredetermined amount of a second IV fluid through a pressure-operatedvalve (e.g. pressure-operated valve 270, pressure-operated valve 870),that is also positioned upstream of the tubing (e.g. tubing 258, tubing858), and at a fluid pressure exceeding a threshold pressure of thepressure-operated valve (e.g. pressure-operated valve 270,pressure-operated valve 870). At block 930, the reservoir pump (e.g.reservoir pump 260, reservoir pump 860) is released. At block 934, oncereleased at block 930, the reservoir pump (e.g. reservoir pump 260,reservoir pump 860) automatically fills itself with the predeterminedamount of the second IV fluid from a source (e.g. source 210, source810) upstream of the reservoir pump (e.g. reservoir pump 260, reservoirpump 860). At block 938, once the reservoir pump (e.g. reservoir pump260, reservoir pump 860) is released at block 930, the pressure-operatedvalve (e.g. pressure-operated valve 270, pressure-operated valve 870)automatically reconfigures itself to receive a third IV fluid from afluid source (e.g. source 210, source 810) upstream of thepressure-operated valve (e.g. pressure-operated valve 270,pressure-operated valve 870) and at a fluid pressure less than thethreshold pressure.

In various embodiments, the fluid source upstream of the reservoir pump(e.g. reservoir pump 260, reservoir pump 860) and the fluid sourceupstream of the pressure-operated valve (e.g. pressure-operated valve270, pressure-operated valve 870) are the same source (e.g. source 210,source 810) and the second and third IV fluids are the same type offluid. In various embodiments, respective upper or proximal ends oftubing 852 (e.g. upstream of pressure-operated valve 270,pressure-operated valve 870) and tubing 854 (e.g. upstream of reservoirpump 260) are configured to operate in fluid communication with the sameIV fluid source (e.g. IV fluid bag 210, IV fluid bag 810) via a Y-splitof tubing (e.g. Y-split 280 in FIGS. 14A-14C). In various embodiments,the fluid source upstream of the reservoir pump (e.g. reservoir pump260, reservoir pump 860) and the fluid source upstream of thepressure-operated valve (e.g. pressure-operated valve 270,pressure-operated valve 870) are different sources and the second andthird IV fluids are different types of fluid. In various embodiments,the first IV fluid is introduced (at block 910) via an injection port(e.g. of port connector 575, port 775), or an inlet port (e.g. port 245)of a three-way stopcock (e.g. stopcock 240) that is disposed downstreamof the pressure-operated valve (e.g. pressure-operated valve 270,pressure-operated valve 870). In various embodiments, the first IV fluidis introduced (at block 910) via an inlet port (e.g. port 575, port 775)of the pressure-operated valve (e.g. pressure-operated valve 270,pressure-operated valve 870) and at a pressure exceeding the thresholdpressure of the pressure-operated valve (e.g. pressure-operated valve270, pressure-operated valve 870). In various embodiments, the third IVfluid is a solution comprising saline and the first IV fluid comprises adrug or an antibiotic.

The inventor has observed that utilizing a chamber including a pluralityof connector ports, where at least the connector port configured toreceive fluid from a gravity-fed IV fluid source is automaticallyoperated, the time and cost necessary for using stopcocks is eliminated.Referring now to FIGS. 10A and 10B, plan views of examples of a chamberaccording to some embodiments are provided. In various embodiments, achamber 1070 is provided including a plurality of connector ports 1071,1072, 1073, 1074. While the illustrated embodiments show an example of achamber 1070 with four (4) connector ports, a chamber 1070 including anysuitable number of connector ports (e.g. three (3), five (5), six (6),etc.) may be selected and utilized. As illustrated in the examples ofFIGS. 10A and 10B, chamber 1070 may include a check valve 1076downstream of connector port 1071. In the illustrated embodiments ofFIG. 10A, check valve 1076 is a normally open swing check valve. In theillustrated embodiments of FIG. 10B, check valve 1076 is a normally opendisc check valve. Any suitable check valve may be utilized for checkvalve 1076. For example, a swing check valve, lift check valve, wafercheck valve, disc check valve, flapper check valve, inline check valve,ball check valve, etc. may be utilized.

Each of the plurality of connector ports (1071, 1072, 1073, 1074) isconfigured to be operably coupled to an end of tubing or a valveconnector. In various embodiments, a connector port is configured to beoperably coupled to a cover (e.g. a cap) to prevent contamination fromentering chamber 1070 when the connector port is not otherwise operablycoupled to an end of tubing or a valve connector. For example, a cap maybe screwed or snapped onto any connector port that is not otherwiseoperably coupled to an end of tubing or a valve connector. Referring toFIGS. 10A and 10B, for example, connector port 1072 may be configured tobe operably coupled to cap 1092, and connector port 1074 may beconfigured to be operably coupled to cap 1094.

Referring now to FIG. 10C, a plan view of an example of a chamberincluding a plurality of connector ports, and examples of valveconnectors, according to some embodiments is provided. As illustrated inthe example of FIG. 10C, an end of a valve connector 1078 including aneedle-free valve may be operably coupled to a connector port (e.g.1074), an end of valve connector 1076, including one or more normallyopen check valves, may be operably coupled to a connector port (e.g.1073), and/or an end of valve connector 1079, including a normally opencheck valve and/or a normally closed check valve, may be operablycoupled to a connector port (e.g. 1072), of chamber 1070. Any suitablevalve connector may be operably coupled to a connector port of chamber1070. For example, the valve connector may include a needle-free valve,an aspiration valve, a trumpet valve, a normally closed check valve, anormally open check valve, a luer, and/or combinations thereof.

In various embodiments, the valve connector (e.g. 1079, FIG. 10C) mayinclude a normally open check valve at one end and a normally closedcheck valve at the other end. In various embodiments, engagement of oneend of the valve connector with a connector port of chamber 1070 willautomatically reposition the respective check valve at such end suchthat normally open check valve will be closed and normally closed valvewill be opened. For example, valve connector 1079 (FIG. 10C) includes anormally open check valve at one end, a normally closed check valve atthe other end, a post 1081, and a post 1083. During operation, if anoperator (e.g. a clinician) desires that both of the check valves insuch a valve connector (e.g. 1079, FIG. 10C) be operated in a normallyopen position, the operator will operably couple the end of the valveconnector (e.g. 1079, FIG. 10C) with the normally closed check valve toa connector port of chamber 1070. Engagement of such end with aconnector port will operate post 1081 to open the normally closed checkvalve. In the illustrated example of FIG. 10C, post 1081 will contactthe hinged disc assembly and apply a force to open the normally closedcheck valve as the respective end of the valve connector is engaged withthe connector port. During operation, if an operator (e.g. a clinician)desires that both of the check valves in such a valve connector (e.g.1079, FIG. 10C) be operated in a normally closed position, the operatorwill operably couple the end of the valve connector (e.g. 1079, FIG.10C) with the normally open check valve to a connector port of chamber1070. Engagement of such end with a connector port will operate post1083 to close the normally open check valve. In the illustratedembodiments of FIG. 10C, post 1083 will contact the hinged disc assemblyand apply a force to close the normally open check valve as therespective end of the valve connector is engaged with the connectorport.

In various embodiments, a plurality of the connector ports arerespectively, operably, coupled to a respective end of tubing or arespective valve connector. For example, a respective end of tubing orvalve connector may be clamped, screwed, or snapped, on or into each ofthe plurality of connector ports. A locking collar may be used tooperably couple a respective end of tubing or valve connector with oneor more of the plurality of connector ports. In various embodiments,each of the plurality of connector ports includes a respective maleand/or female end to connect to an end of tubing or a valve connector.In some embodiments, a respective male and/or female adapter may beutilized to connect of each the plurality of connector ports (1071,1072, 1073, 1074) to an end of tubing or a valve connector. In someembodiments, one or more of the plurality of connector ports are shapedto achieve a snap-on and snap-off engagement with ends of valveconnectors.

With reference to FIGS. 10D and 10E, plan views of examples of a chamberincluding a plurality of connector ports respectively connected to endsof tubing and examples of valve connectors according to some embodimentsare provided. As illustrated in the example of FIG. 10D, an end of avalve connector 1078 including a needle-free valve may be operablycoupled to connector port 1074, an end of tubing 1052 may be operablycoupled to connector port 1071, and an end of tubing 1058 may beoperably coupled to connector port 1073, of chamber 1070. As illustratedin the example of FIG. 10E, an end of valve connector 1079, including anormally closed check valve, may be operably coupled to connector port1074, an end of tubing 1052 may be operably coupled to connector port1073, and an end of tubing 1058 may be operably coupled to connectorport 1073, of chamber 1070. In the illustrated example of FIG. 10E, post1081 of valve connector 1079 contacts the hinged disc assembly andapplies a force to open the normally closed check valve as therespective end of the valve connector 1079 is engaged with the connectorport 1072.

With reference to FIGS. 10F and 10G, plan views of examples of a chamberincluding a plurality of connector ports respectively connected to endsof tubing and examples of valve connectors according to some embodimentsare provided. In various embodiments, a first part of valve connectormay operably engage a second part of valve connector 1089. Asillustrated in the examples of FIGS. 10F and 10G, a valve connector 1089may include a first part with a larger circumference than acircumference of a second part. In the illustrated examples, a portionof the first part is internally threaded to threadably engage 1067 anexternally threaded portion of the second part. Any suitable techniquefor operable engagement between the first and second part of valveconnector 1089 may be utilized. For example, one or both of the firstand second parts of valve connector 1089 may include a notch, ridge,rib, and/or threads to permit an operator to operate the valve connectorbetween a first and a second position. In various embodiments, the firstpart of valve connector 1089 may be operated between the first positionand the second position by twisting the first part in acounter-clockwise or clockwise direction relative to the second part. Insome embodiments, a full rotation of a portion of the first part arounda portion of second part is required to operate the valve connectorbetween a first position and a second position. In some embodiments, apartial rotation (e.g. ¼ rotation, ½ rotation) is required. In someembodiments, a plurality of full rotations are required. In someembodiments, a first part is pushed toward a second part and thentwisted relative to the second part to operate the valve connector 1089between a first position and a second position.

In the illustrated example of FIG. 10F, valve connector 1089 is in afirst position such that a check valve including plunger assembly 1085is a normally open check valve. In the illustrated example, the proximalend of valve connector 1089 (relative to chamber 1070) may be operablycoupled to connector port 1072 and the distal end of valve connector1089 may be operably coupled to an end of tubing to receive IV fluidfrom an upstream source. In the illustrated example, with the proximalend of valve connector 1089 operably coupled to connector port 1072, IVfluid from an upstream source is permitted to flow through valveconnector 1089 and past plunger assembly 1085 into chamber 1070 viaconnector port 1072. In the illustrated example, with the proximal endof valve connector 1089 operably coupled to connector port 1072, fluidpressure of IV fluid received into chamber 1070 via another connectorport (e.g. 1071, 1074, 1073) may operate to shut the normally open checkvalve in valve connector 1089 by operating plunger assembly 1085 toprevent the IV fluid from flowing toward the distal end (relativechamber 1070) of valve connector 1089.

Referring now to the illustrated example of FIG. 10G, valve connector1089 has been operated from the first position (illustrated in FIG. 10F)to a second position (illustrated in FIG. 10G) such that the check valveincluding plunger assembly 1085 is a normally closed check valve. In theillustrated example, the proximal end of valve connector 1089 (relativeto chamber 1070) may be operably coupled to connector port 1072 and thedistal end of valve connector 1089 may be operably coupled to an end oftubing to receive IV fluid from an upstream source. In the illustratedexample, with the proximal end of valve connector 1089 operably coupledto connector port 1072, IV fluid from an upstream source and receivedvia the distal end (relative chamber 1070) of valve connector 1089 isprevented from flowing through valve connector 1089 and past plungerassembly 1085 into chamber 1070 via connector port 1072 until the fluidpressure of such IV fluid exceeds a threshold biasing pressure of thespring of plunger assembly 1085. In the illustrated example, with theproximal end of valve connector 1089 operably coupled to connector port1072, plunger assembly 1085 also prevents IV fluid received into chamber1070 via another connector port (e.g. 1071, 1074, 1073) from flowingtoward the distal end (relative chamber 1070) of valve connector 1089.

In various embodiments, chamber 1070 is configured to operate in fluidcommunication with an upstream first source of a first IV fluid (e.g.FIG. 2 source 210, FIG. 8 source 810) via a first one (e.g. 1071) of theplurality of connector ports of chamber 1070. Any suitable fluid forintravenous administration to a subject may be provided as the first IVfluid as described above for first IV fluid source of FIG. 2. In variousembodiments, an end of tubing (e.g. FIG. 2 tubing 252, FIG. 8 tubing852) may be operably coupled to connector port 1071 of chamber 1070 suchthat chamber 1070 receives the first IV fluid gravity fed from the firstIV fluid source (e.g. FIG. 2 source 210, FIG. 8 source 810) viaconnector port 1071.

In various embodiments, chamber 1070 is configured to, during operation,pass therethrough the chamber 1070 to tubing downstream (e.g. FIG. 2tubing 258, FIG. 8 tubing 858) of the chamber 1070, under a firstpressure condition, the first IV fluid from the upstream first IV fluidsource (e.g. FIG. 2 source 210, FIG. 8 source 810) via a second one(e.g. 1073) of the plurality of connector ports 1071, 1072, 1073, 1074.In various embodiments, an end of tubing (e.g. FIG. 2 tubing 258, FIG. 8tubing 858) may be operably coupled to connector port 1073 of chamber1070, and an end of tubing (e.g. FIG. 2 tubing 252, FIG. 8 tubing 852)may be operably coupled to connector port 1071 of chamber 1070. Invarious embodiments, during operation and under a first pressurecondition (e.g. the first pressure may be the fluid pressure ofgravity-fed first IV fluid entering chamber 1070 via tubing 252, 852 andconnector port 1071), chamber 1070 may pass therethrough the first IVfluid gravity fed from the first IV fluid source (e.g. FIG. 2 source210, FIG. 8 source 810) to tubing downstream (e.g. FIG. 2 tubing 258,FIG. 8 tubing 858) of the chamber 1070 via connector ports 1071 and1073.

In various embodiments, a third one (e.g. 1072) of the plurality ofconnector ports of chamber 1070 is configured to connect to an end oftubing or a valve connector such that, during operation, the chamber1070 is configured to, under a second pressure condition higher than thefirst pressure condition, pass therethrough, to the tubing downstream(e.g. FIG. 2 tubing 258, FIG. 8 tubing 858) of the chamber 1070, asecond IV fluid from a second IV fluid source via the third (e.g. 1072)and second (e.g. 1073) connector ports, to prevent flow of the first IVfluid into the tubing downstream (e.g. FIG. 2 tubing 258, FIG. 8 tubing858) of the chamber 1070, and to prevent flow of the second IV fluidthrough the first connector port (e.g. 1071). In various embodiments, anend of tubing (e.g. FIG. 2 tubing 256, FIG. 8 tubing 856) may beoperably coupled to connector port 1072, an end of tubing (e.g. FIG. 2tubing 258, FIG. 8 tubing 858) may be operably coupled to connector port1073, and an end of tubing (e.g. FIG. 2 tubing 252, FIG. 8 tubing 852)may be operably coupled to connector port 1071, of chamber 1070. In someembodiments, an end of a valve connector including a normally closedcheck valve (e.g. 1079) may be operably coupled to connector port 1072and an end of tubing (e.g. FIG. 2 tubing 256, FIG. 8 tubing 856) may beoperably coupled to the other end of the valve connector (e.g. 1079).

In various embodiments, the tubing (e.g. FIG. 2 tubing 256, FIG. 8tubing 856), or the valve connector (e.g. 1079), operably coupled toconnector port 1072 is also operably coupled to a reservoir pump (e.g.FIG. 2 reservoir pump 260, FIG. 8 reservoir pump 860) configured toautomatically refill itself with second IV fluid from a second upstreamfluid source. In various embodiments, the first IV fluid source (e.g.FIG. 6 source 610 a) and the IV fluid source (e.g. FIG. 6 source 610 b)of the reservoir pump (e.g. FIG. 6 reservoir pump 660 b) are differentIV fluid sources as described above for FIGS. 2 and 6. In variousembodiments, the first IV fluid source (e.g. FIG. 2 source 210, FIG. 8source 810) and the IV fluid source of the reservoir pump (e.g. FIG. 2reservoir pump 260, FIG. 8 reservoir pump 860) are the same IV fluidsource (e.g. FIG. 2 source 210, FIG. 8 source 810) as described abovefor FIGS. 2 and 8.

In various embodiments, during a reservoir pump-use operation (e.g. aflushing operation), pressurized second IV fluid is received from areservoir pump (e.g. FIG. 2 reservoir pump 260, FIG. 8 reservoir pump860) and into chamber 1070 via tubing (e.g. FIG. 2 tubing 256, FIG. 8tubing 856) operably coupled to a connector port (e.g. 1072, 1074) andsuch connector port. In various embodiments, the pressurized second IVfluid applies a fluid pressure to shut check valve 1076 of chamber 1070as described above for check valves 366 a, 466 a, 576 for FIGS. 3B, 3D,4A, 4B, 5E. In some embodiments, an end of a valve connector including anormally closed check valve (e.g. 1079) may be operably coupled to theselected connector port (e.g. 1072, 1074) and the end of tubing (e.g.FIG. 2 tubing 256, FIG. 8 tubing 856) may be operably coupled to theother end of the valve connector (e.g. 1079). In various embodiments,the pressurized second IV fluid applies a fluid pressure to open thenormally closed check valve of the valve connector (e.g. 1079) asdescribed above for check valves 366 b, 466 b for FIGS. 3B, 3D, 4A, and4B. In various embodiments, during a reservoir pump-use operation (e.g.a flushing operation), pressurized second IV fluid is received from areservoir pump (e.g. FIG. 2 reservoir pump 260, FIG. 8 reservoir pump860) and into chamber 1070 via a valve connector (e.g. 1079), operablycoupled to connector port 1072, and without intervening tubing (e.g.FIG. 2 tubing 256, FIG. 8 tubing 856).

In various embodiments, when the fluid pressure of the second IV fluid,received from a reservoir pump (e.g. FIG. 2 reservoir pump 260, FIG. 8reservoir pump 860) via tubing (e.g. FIG. 2 tubing 256, FIG. 8 tubing856) and the selected connector port (e.g. 1072, 1074), is at or exceedsa threshold pressure of check valve 1076, check valve 1076 shuts toblock first IV fluid flow from upstream tubing (e.g. FIG. 2 tubing 252,FIG. 8 tubing 852) and the selected connector port (e.g. 1071), and toprovide second IV fluid communication between the inlet from theselected connector port (e.g. 1072, 1074) and upstream tubing (e.g. FIG.2 tubing 256, FIG. 8 tubing 856) and the outlet to downstream tubing(e.g. FIG. 2 tubing 258, FIG. 8 tubing 858) via selected connector port(e.g. 1073). When the fluid pressure received from reservoir pump (e.g.FIG. 2 reservoir pump 260, FIG. 8 reservoir pump 860) via tubing (e.g.FIG. 2 tubing 256, FIG. 8 tubing 856) and the selected connector port(e.g. 1072, 1074) is again less than the threshold pressure of checkvalve 1076, check valve 1076 re-opens to re-open the inlet from upstreamtubing (e.g. FIG. 2 tubing 252, FIG. 8 tubing 852) and the selectedconnector port (e.g. 1071), and provide first IV fluid communicationbetween the inlet from upstream tubing (e.g. FIG. 2 tubing 252, FIG. 8tubing 852) and the selected connector port (e.g. 1071) and the outletto downstream tubing (e.g. FIG. 2 tubing 258, FIG. 8 tubing 858) viaselected connector port (e.g. 1073).

In various embodiments, an end of a valve connector including a needlefree valve (e.g. 1078) or a luer lock (not shown) may be operablycoupled to connector port 1074, an end of tubing (e.g. FIG. 2 tubing258, FIG. 8 tubing 858) may be operably coupled to connector port 1073,and an end of tubing (e.g. FIG. 2 tubing 252, FIG. 8 tubing 852) may beoperably coupled to connector port 1071, of chamber 1070. In variousembodiments, pressurized second IV fluid injected via a syringe (notshown) inserted into a male luer in the valve connector (e.g. 1078)(including a needle free valve or a luer lock), and into chamber 1070via the selected connector port (e.g. 1072, 1074), may apply a fluidpressure to shut check valve 1076 of chamber 1070 as described above forcheck valves 366 a, 466 a, 576 for FIGS. 3B, 3D, 4A, 4B, 5E.

In various embodiments, when the fluid pressure of the second IV fluid,received from a syringe (not shown) inserted into a male luer of thevalve connector (e.g. 1078) (including a needle free valve or a luerlock) via the selected connector port (e.g. 1072, 1074), is at orexceeds a threshold pressure of check valve 1076, check valve 1076 shutsto block first IV fluid flow from upstream tubing (e.g. FIG. 2 tubing252, FIG. 8 tubing 852) and the selected connector port (e.g. 1071), andto provide second IV fluid communication between the valve connectorinlet via the selected connector port (e.g. 1072, 1074) and the outletto downstream tubing (e.g. FIG. 2 tubing 258, FIG. 8 tubing 858) viaselected connector port (e.g. 1073). When the fluid pressure receivedfrom the valve connector via selected connector port (e.g. 1072, 1074)is again less than the threshold pressure of check valve 1076, checkvalve 1076 re-opens to re-open the inlet from upstream tubing (e.g. FIG.2 tubing 252, FIG. 8 tubing 852) and the selected connector port (e.g.1071), and provide first IV fluid communication between the inlet fromupstream tubing (e.g. FIG. 2 tubing 252, FIG. 8 tubing 852) and theselected connector port (e.g. 1071) and the outlet to downstream tubing(e.g. FIG. 2 tubing 258, FIG. 8 tubing 858) via selected connector port(e.g. 1073). In various embodiments, subsequent to injecting second IVfluid into chamber 1070 via the valve connector including a needle freevalve (e.g. 1078) or a luer lock (not shown) and the selected connectorport (e.g. 1072, 1074), a flushing operation using reservoir pump (e.g.FIG. 2 reservoir pump 260, FIG. 8 reservoir pump 860) can be initiatedvia tubing (e.g. FIG. 2 tubing 256, FIG. 8 tubing 856) and anotherselected connector port (e.g. 1074, 1072) as described above.

In various embodiments, a fourth one (e.g. 1074) of the plurality ofconnector ports of chamber 1070 is configured to connect to an end oftubing or a valve connector such that, during operation, the chamber1070 is configured to, under a third pressure condition higher than thefirst pressure condition, pass therethrough, to the tubing downstream(e.g. FIG. 2 tubing 258, FIG. 8 tubing 858) of the chamber 1070, a thirdIV fluid from a third IV fluid source via the fourth (e.g. 1074) andsecond (e.g. 1073) connector ports, to prevent flow of the first IVfluid into the tubing downstream (e.g. FIG. 2 tubing 258, FIG. 8 tubing858) of the chamber 1070, and to prevent flow of the third IV fluidthrough the first connector port (e.g. 1071). In various embodiments, anend of tubing (e.g. FIG. 2 tubing 256, FIG. 8 tubing 856) may beoperably coupled to the selected connector port 1074, an end of tubing(e.g. FIG. 2 tubing 258, FIG. 8 tubing 858) may be operably coupled toconnector port 1073, and an end of tubing (e.g. FIG. 2 tubing 252, FIG.8 tubing 852) may be operably coupled to connector port 1071, of chamber1070. In some embodiments, an end of a valve connector including anormally closed check valve (e.g. 1079) may be operably coupled to theselected connector port 1074 and an end of tubing (e.g. FIG. 2 tubing256, FIG. 8 tubing 856) may be operably coupled to the other end of thevalve connector (e.g. 1079).

In some embodiments, an end of tubing (e.g. FIG. 6 tubing 656 a) may beoperably coupled to the selected connector port 1074, an end of tubing(e.g. FIG. 6 tubing 656 b) may be operably coupled to connector port1072, an end of tubing (e.g. FIG. 6 tubing 652) may be operably coupledto connector port 1071, and an end of tubing (e.g. FIG. 6 tubing 658 b)may be operably coupled to connector port 1073, of chamber 1070. In someembodiments, a plurality of connector ports of chamber 1070 can receiverespective gravity-fed IV fluids from respective IV fluid sources. Forexample, an end of tubing (e.g. FIG. 2 tubing 252, FIG. 8 tubing 852)may be operably coupled to connector port 1071 to receive a first IVfluid gravity-fed from an IV fluid source (e.g. FIG. 2 IV fluid bag 210,FIG. 8 IV fluid bag 810) via connector port 1071 and check valve 1076,and another end of tubing (not shown) may be operably coupled to anotherselected connector port (e.g. 1074) to receive a second IV fluidgravity-fed from another IV fluid source (not shown) via the anotherselected connector port (e.g. 1074). In some embodiments, the anotherend of tubing (not shown) may be operably coupled to the anotherselected connector port (e.g. 1074) via a valve connector. In someembodiments, the valve connector may include a check valve (e.g. anormally open check valve).

In some embodiments, an end of tubing (e.g. FIG. 2 tubing 252, FIG. 8tubing 852) may be operably coupled to connector port 1071 to receive afirst IV fluid gravity-fed from an IV fluid source (e.g. FIG. 2 IV fluidbag 210, FIG. 8 IV fluid bag 810) via connector port 1071 and checkvalve 1076, another end of tubing (not shown) may be operably coupled toconnector port 1074 to receive a second IV fluid gravity-fed fromanother IV fluid source (not shown) via connector port 1074 and a valveconnector including a normally open check valve, an end of tubing (e.g.FIG. 2 tubing 258, FIG. 8 tubing 858) may be operably coupled toconnector port 1073, and an end of tubing (e.g. FIG. 2 tubing 256, FIG.8 tubing 856) may be operably coupled to the selected connector port1074. In various embodiments, during a reservoir pump-use operation(e.g. a flushing operation), pressurized third IV fluid is received froma reservoir pump (e.g. FIG. 2 reservoir pump 260, FIG. 8 reservoir pump860) and into chamber 1070 via tubing (e.g. FIG. 2 tubing 256, FIG. 8tubing 856) operably coupled to connector port 1072 and such connectorport 1072. In various embodiments, the pressurized third IV fluidapplies a fluid pressure to shut check valve 1076 of chamber 1070, andthe check valve in the valve connector operably coupled to connectorport 1074, as described above for check valves 366 a, 466 a, 576 forFIGS. 3B, 3D, 4A, 4B, 5E. In various embodiments, when the fluidpressure of the third IV fluid, received from a reservoir pump (e.g.FIG. 2 reservoir pump 260, FIG. 8 reservoir pump 860) via tubing (e.g.FIG. 2 tubing 256, FIG. 8 tubing 856) and connector port 1072, is at orexceeds a respective threshold pressure of check valve 1076 and thecheck valve in the valve connector operably coupled to connector port1074, such check valves respectively shut to block first IV fluid flowfrom upstream tubing (e.g. FIG. 2 tubing 252, FIG. 8 tubing 852) andconnector port 1071 and to block second IV fluid flow from the upstreamtubing operably coupled to connector port 1074, and to provide second IVfluid communication between the inlet from connector port 1072 andupstream tubing (e.g. FIG. 2 tubing 256, FIG. 8 tubing 856) and theoutlet to downstream tubing (e.g. FIG. 2 tubing 258, FIG. 8 tubing 858)via connector port 1073. When the fluid pressure received from reservoirpump (e.g. FIG. 2 reservoir pump 260, FIG. 8 reservoir pump 860) viatubing (e.g. FIG. 2 tubing 256, FIG. 8 tubing 856) and connector port1072 is again less than the respective threshold pressure of check valve1076 and the check valve in the valve connector operably coupled toconnector port 1074, such check valves re-open to re-open the inlet fromupstream tubing (e.g. FIG. 2 tubing 252, FIG. 8 tubing 852) andconnector port 1071 and the inlet from the upstream tubing operablycoupled to connector port 1074, and provide respective first IV fluidand second IV fluid communication between the respective inlets and theoutlet to downstream tubing (e.g. FIG. 2 tubing 258, FIG. 8 tubing 858).

In some embodiments, an end of tubing (e.g. FIG. 2 tubing 256, FIG. 8tubing 856) may be operably coupled to the selected connector port 1074,an end of a valve connector including a needle free valve (e.g. 1078) ora luer lock (not shown) may be operably coupled to connector port 1072,an end of tubing (e.g. FIG. 2 tubing 258, FIG. 8 tubing 858) may beoperably coupled to connector port 1073, and an end of tubing (e.g. FIG.2 tubing 252, FIG. 8 tubing 852) may be operably coupled to connectorport 1071, of chamber 1070.

The inventor has observed that utilizing a chamber including a pluralityof connector ports, where at least the connector port configured toreceive fluid from a gravity-fed IV fluid source is automaticallyoperated, where any suitable number of connector ports may be selectedand utilized, and where any suitable IV fluid sources and sinks can beoperably coupled to such chamber via such connector ports and via anyselected valve connector or selected tubing, his solutions describedherein are easily scalable such that numerous different IV fluids can beinjected and flushed efficiently, cost-effectively, and accurately.Referring now to FIG. 11, a perspective view of an intravenous (IV)fluid administration system according to some embodiments is provided.As illustrated in FIG. 11, some embodiments include a source of a firstIV fluid 1110, a drip chamber 1120, a roller clamp 1130, tubing 1152downstream of roller clamp 1130 as described above for FIGS. 2 and10A-10E, a chamber 1170 as described above for FIGS. 10A-10E, and tubing1158 downstream of chamber 1170 as described above for FIGS. 2 and10A-10E. As shown in FIG. 11, IV fluid administration system 1100 doesnot include a stopcock.

With reference to FIG. 12, a flow chart illustrating a method 1200 offlushing a line of an intravenous fluid administration system accordingto some embodiments is provided. At block 1210, a first IV fluid isintroduced into a first connector port (e.g. 1072) of a chamber (e.g.1070) comprising a plurality of connector ports (e.g. 1071, 1072, 1073,1074) and at a fluid pressure exceeding a threshold pressure of thechamber. In various embodiments, the first IV fluid includes a drug, anantibiotic, or an anesthetic. In various embodiments, the thresholdpressure of the chamber is a threshold pressure of a check valve (e.g.1076) disposed downstream of a fourth connector port (e.g. 1071) of thechamber (e.g. 1070). At block 1220, the introducing step (at block 1210)automatically prevents the flow of the first IV fluid through the fourthconnector port (e.g. 1071) of the chamber (e.g. 1070). In variousembodiments, the introducing step (at block 1210) automatically shutsthe check valve (e.g. 1076) disposed downstream of the fourth connectorport (e.g. 1071) of the chamber (e.g. 1070) to prevent the flow of thefirst IV fluid through the fourth connector port.

At block 1230, the first IV fluid is introduced into tubing (e.g. 1158,FIG. 2 tubing 258, FIG. 8 tubing 858) configured to transport IV fluidfor intravenous infusion to a subject (not shown) via a second connectorport (e.g. 1073) of the chamber. At block 1240, a second IV fluid isintroduced into a third connector port (e.g. 1074) of the chamber (e.g.1070) at a fluid pressure exceeding a threshold pressure of the chamber.In various embodiments, the second IV fluid is a solution includingsaline. In various embodiments, the introducing step (at block 1240),includes operating a reservoir pump (e.g. FIG. 2 reservoir pump 260,FIG. 8 reservoir pump 860) upstream of the third connector port (e.g.1074) of the chamber (e.g. 1070) as described above for FIGS. 2, 3A-4B,8, and 10A-10E. At block 1250, the introducing step (at block 1240)automatically prevents the flow of the second IV fluid through thefourth connector port (e.g. 1071) of the chamber (e.g. 1070). In variousembodiments, the introducing step (at block 1240) automatically shutsthe check valve (e.g. 1076) disposed downstream of the fourth connectorport (e.g. 1071) of the chamber (e.g. 1070) to prevent the flow of thesecond IV fluid through the fourth connector port. At block 1250, thesecond IV fluid is introduced into tubing (e.g. 1158, FIG. 2 tubing 258,FIG. 8 tubing 858) configured to transport IV fluid for intravenousinfusion to a subject (not shown) via the second connector port (e.g.1073) of the chamber.

In various embodiments, the method 1200 includes releasing a reservoirpump (e.g. FIG. 2 reservoir pump 260, FIG. 8 reservoir pump 860),operably coupled to the chamber (e.g. 1070) via the third connector port(e.g. 1074), such that the reservoir pump automatically fills itselfwith second IV fluid from a source (e.g. FIG. 2 source 210, FIG. 8source 810) upstream of the reservoir pump, and such that the chamber(e.g. 1070) automatically reconfigures itself to receive a third IVfluid from a fluid source (e.g. FIG. 2 source 210, FIG. 8 source 810)upstream of the chamber (e.g. 1070) and at a fluid pressure less thanthe threshold pressure of the chamber. In various embodiments, thechamber (e.g. 1070) receives the third IV fluid via the fourth connectorport (e.g. 1071). In various embodiments, the third IV fluid is asolution including saline. In various embodiments, each of theintroducing step (at block 1240) and the introducing step (at block1210) automatically prevents the flow of the third IV fluid into thetubing (e.g. 1158, FIG. 2 tubing 258, FIG. 8 tubing 858) configured totransport IV fluid for intravenous infusion to a subject (not shown) viathe second connector port (e.g. 1073) of the chamber. In variousembodiments, the introducing steps (at blocks 1210 and 1240) eachautomatically shut the check valve (e.g. 1076) disposed downstream ofthe fourth connector port (e.g. 1071) of the chamber (e.g. 1070) toprevent the flow of the third IV fluid through the check valve (e.g.1076).

Referring now to FIG. 13, a flow chart illustrating a method 1300according to some embodiments is provided. At block 1310, a first one(e.g. 1071) of a plurality of connector ports (e.g. 1071, 1072, 1073,1074) of a chamber (e.g. 1070) is operably coupled to an upstream firstsource of a first IV fluid (e.g. 1110, FIG. 2 source 210, FIG. 8 source810). At block 1320, a third one (e.g. 1074) of the plurality ofconnector ports of the chamber (e.g. 1070) is operably coupled to an endof tubing or a valve connector as described above for FIGS. 10A-10E. Invarious embodiments, the end of tubing or the valve connector isoperably coupled to a reservoir pump (e.g. FIG. 2 reservoir pump 260,FIG. 8 reservoir pump 860) configured to automatically refill itselfwith the second IV fluid from a second upstream IV fluid source (e.g.FIG. 2 source 210, FIG. 6 source 610 a or 610 b, FIG. 8 source 810) asdescribed above for FIGS. 2, 3A-4B, 6, 8, and 10A-10E. In variousembodiments, the first and second IV fluid sources are the same source(e.g. FIG. 2 source 210, FIG. 6 source 610 a, FIG. 8 source 810) and thefirst and second IV fluids are the same type of fluid. In someembodiments, the first and second IV fluid sources are different sources(e.g. FIG. 6 source 610 a and source 610 b) and the first and second IVfluids are different types of fluid. In some embodiments, the valveconnector includes a luer. In some embodiments, the valve connectorincludes a needle-free valve, an aspiration valve, a trumpet valve, or anormally closed check valve.

At block 1330, during operation, a pressure condition is evaluated as towhether a first pressure condition exists. At block 1350, if a firstpressure condition is determined to exist (at block 1330), the first IVfluid is passed through the chamber (e.g. 1070) to tubing downstream(e.g. 1058, 1158, FIG. 2 tubing 258, FIG. 8 tubing 858) of the chamber(e.g. 1070) via the first connector port (e.g. 1071) and a second one(e.g. 1073) of the plurality of connector ports of the chamber (e.g.1070). At block 1340, during operation, a pressure condition isevaluated as to whether a second pressure condition higher than thefirst pressure condition exists. At block 1360, if a second pressurecondition higher than the first pressure condition is determined toexist (at block 1340), the second IV fluid is passed through the chamber(e.g. 1070) to tubing downstream (e.g. 1058, 1158, FIG. 2 tubing 258,FIG. 8 tubing 858) of the chamber (e.g. 1070) via the third (e.g. 1074)and second (e.g. 1073) connector ports of the chamber (e.g. 1070). Atblock 1360, if the second pressure condition is determined to exist (atblock 1340), the first IV fluid is prevented from flowing into thetubing downstream (e.g. 1058, 1158, FIG. 2 tubing 258, FIG. 8 tubing858) of the chamber (e.g. 1070). At block 1370, if the second pressurecondition is determined to exist (at block 1340), the second IV fluid isprevented from flowing through the first connector port (e.g. 1071) ofthe chamber (e.g. 1070).

In some embodiments, various steps of the method can be implemented(e.g., introducing IV fluids) by a general purpose computer programmedin accordance with the principals discussed herein. Certain featuresthat are described in this specification in the context of separateembodiments can also be implemented in combination in a singleembodiment. Conversely, various features that are described in thecontext of a single embodiment can also be implemented in multipleembodiments separately or in any suitable sub-combination. Moreover,although features may be described above as acting in certaincombinations and even initially claimed as such, one or more featuresfrom a claimed combination may in some cases be excised from thecombination, and the claimed combination may be directed to asub-combination or variation of a sub-combination.

Similarly, while operations are depicted in the drawings in a particularorder, this should not be understood as requiring that such operationsbe performed in the particular order shown or in sequential order, orthat all illustrated operations be performed, to achieve desirableresults. In certain circumstances, multitasking and parallel processingcan be advantageous.

While various embodiments are described herein, it is to be understoodthat the embodiments described are illustrative only and that the scopeof the subject matter is to be accorded a full range of equivalents,many variations and modifications naturally occurring to those of skillin the art from a perusal hereof.

What I claim is:
 1. A reservoir pump for use in flushing fluid in anintravenous line toward a subject, the reservoir pump comprising: aninlet port configured to be operably coupled to upstream tubing and tooperate in fluid communication with a source of an intravenous fluid viathe upstream tubing; an outlet port configured to operate in fluidcommunication with a pressure-operated valve; a housing defining achamber, the chamber in fluid communication with the inlet port and theoutlet port, the chamber having a filling volume; a plunger assemblyincluding a piston, the piston translatably mounted within the housing;wherein the piston, during operation, is configured to: translatebetween a first position and a second position in the housing to deliverintravenous fluid in the filling volume of the chamber to thepressure-operated valve via the outlet port; and translate between thesecond position and the first position in the chamber to automaticallyrefill the filling volume of the chamber with intravenous fluid via theinlet port; wherein the housing of the reservoir pump comprises externalthreads, wherein the external threads of the housing of the reservoirpump are configured to engage internal threads of an external device;and wherein, during operation, rotation of the external device relativeto the housing of the reservoir pump adjusts the first position of thepiston within the chamber of the reservoir pump to adjust the fillingvolume of the chamber of the reservoir pump.
 2. The reservoir pump ofclaim 1, wherein the piston is further configured to, during operationof the piston between the first position and the second position,deliver the intravenous fluid from the chamber at a pressure at orexceeding a threshold pressure of the pressure-operated valve and as aflushing fluid for another intravenous fluid in tubing downstream of thepressure operated valve.
 3. The reservoir pump of claim 1, furthercomprising an inlet check valve configured to, during operation of thepiston between the first position and the second position, shut toprevent intravenous fluid in the chamber from flowing from the chambertoward the source via the inlet port.
 4. The reservoir pump of claim 3,further comprising an outlet check valve configured to, during operationof the piston between the first position and the second position, opento permit intravenous fluid in the chamber to flow from the chambertoward the pressure-operated valve and via the outlet port.
 5. Thereservoir pump of claim 1, wherein the plunger assembly furthercomprises a spring configured to bias the piston toward the firstposition.
 6. The reservoir pump of claim 1, wherein the reservoir pumpis a closed system reservoir pump, wherein the closed system reservoirpump further comprises a collapsible bellows operably coupled at a firstend to the plunger assembly and at a second end to the housing, whereina closed volume is defined by the collapsible bellows, the housing, andthe plunger assembly.
 7. An apparatus for dispensing intravenous fluidtoward a subject, comprising: a spike comprising a plurality of fluiddistribution chambers contained therein, the spike configured to: duringoperation, dispense fluid from an upstream fluid source through one ofthe fluid distribution chambers of the spike and toward an inlet port ofa downstream pressure-operated valve via first tubing operably coupledto the one of the fluid distribution chambers of the spike; and duringoperation, dispense fluid from the upstream fluid source through anotherone of the fluid distribution chambers of the spike and toward an inletport of a downstream reservoir pump via second tubing operably coupledto the another one of the fluid distribution chambers of the spike; thepressure-operated valve configured to: during operation, under a firstpressure condition, pass therethrough to an outlet port of thepressure-operated valve fluid received via the inlet port of thepressure-operated valve; and during operation, under a second pressurecondition higher than the first pressure condition, pass therethrough tothe outlet port fluid received from the reservoir pump; and a flowcontrol device comprising: the reservoir pump; the pressure-operatedvalve; and a housing interconnecting the reservoir pump and thepressure-operated valve and defining a chamber therebetween wherein thepressure-operated valve is further configured to, during operation,under the second pressure condition, pass therethrough to the outletport fluid received from the reservoir pump via the chamber.
 8. Theapparatus of claim 7, wherein the pressure-operated valve is furtherconfigured to, during operation under the second pressure condition,automatically shut off fluid communication to the flow control devicevia the inlet port of the pressure-operated valve.
 9. The apparatus ofclaim 7, wherein the reservoir pump is further configured to, duringoperation under the second pressure condition, automatically shut offfluid communication to the flow control device via the inlet port of thereservoir pump.
 10. A fluid administration system for use in controllingthe dispensing of intravenous fluids toward a subject comprising: aspike comprising a plurality of fluid distribution chambers containedtherein, the spike configured to: during operation, dispense fluid froman upstream fluid source through a first one of the fluid distributionchambers of the spike and toward a first inlet port of apressure-operated valve portion of a downstream flow control device viafirst tubing operably coupled to the first one of the fluid distributionchambers of the spike; and during operation, dispense fluid from thefirst fluid source through a second one of the fluid distributionchambers of the spike and toward a second inlet port of a reservoir pumpportion of the downstream flow control device via second tubing operablycoupled to the second one of the fluid distribution chambers of thespike; and the downstream flow control device comprising: a housinginterconnecting the reservoir pump portion and the pressure-operatedvalve portion and defining a chamber therebetween; the pressure-operatedvalve portion configured to operate in fluid communication with theupstream fluid source via the first inlet port, the first tubing, andthe first one of the fluid distribution chambers of the spike, thepressure-operated valve portion of the downstream flow control devicefurther configured to, during operation under a first pressurecondition, pass therethrough the fluid toward an outlet port; thereservoir pump portion configured to operate in fluid communication withthe upstream fluid source via the second inlet port, the second tubing,and the second one of the fluid distribution chambers of the spike, thereservoir pump portion of the downstream flow control device furtherconfigured to operate in fluid communication with the pressure-operatedvalve portion via the chamber; and the pressure-operated valve portionfurther configured to, during operation under a second pressurecondition higher than the first pressure condition, automatically shutoff fluid communication via the first inlet port and dispense fluid fromthe chamber toward the outlet port.
 11. The fluid administration systemof claim 10, wherein the reservoir pump portion of the downstream flowcontrol device is further configured to, during operation, automaticallyrefill a filling volume of the chamber with the fluid via the secondinlet port, the second tubing, and the second one of the fluiddistribution chambers of the spike.
 12. The fluid administration systemof claim 10, wherein the reservoir pump portion of the downstream flowcontrol device further comprises a check valve, wherein the check valveis configured to, during operation: under the first pressure condition,pass therethrough toward the chamber the fluid received via the secondinlet port of the reservoir pump portion of the downstream flow controldevice; and under the second pressure condition, automatically shut toprevent the fluid in the chamber from flowing out from the second inletport of the reservoir pump portion of the downstream flow controldevice.
 13. The fluid administration system of claim 10, wherein theupstream fluid source is a bag, and the spike is further configured topenetrate the upstream fluid source.
 14. The fluid administration systemof claim 10, wherein the reservoir pump portion of the downstream flowcontrol device further comprises: a plunger assembly comprising apiston, the piston translatably mounted within the chamber; and whereinthe piston, during operation, is configured to: translate between afirst position and a second position in the chamber to dispense thefluid from the chamber and into the pressure-operated valve portion ofthe downstream flow control device at the second pressure condition; andtranslate between the second position and the first position in thechamber to automatically refill a filling volume of the chamber with thefluid received via the second inlet port of the reservoir pump portionof the downstream flow control device, the second tubing, and the secondone of the fluid distribution chambers of the spike.
 15. The fluidadministration system of claim 14, wherein the reservoir pump portion ofthe downstream flow control device is a closed system reservoir pumpportion, wherein the closed system reservoir pump portion furthercomprises further comprises a collapsible bellows operably coupled at afirst end to the plunger assembly and at a second end to the housing,wherein a closed volume is defined by the collapsible bellows, thehousing, and the plunger assembly.
 16. The apparatus of claim 7, whereinthe upstream fluid source is a bag, and the spike is further configuredto penetrate the upstream fluid source.